SENTRADINE  - ranitidine hydrochloride tablet 
Physician Therapeutics LLC

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Ranitidine

The active ingredient in ranitidine tablets USP 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:

Ranitidine Structural Formula The empirical formula is C13H22N4O3S -HCl, representing a molecular weight of 350.87. Ranitidine HCl USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor. Each ranitidine tablet USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FDandC Red No. 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin Each ranitidine tablet USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FDandC Red No. 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin.

CLINICAL PHARMACOLOGY Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.

Pharmacokinetics:

Absorption: Ranitidine is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 ng/mL occurring 2 to 3 hours after a 150-mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of ranitidine, probably by delaying gastric emptying and transit time. In one study, simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of ranitidine. Distribution: The volume of distribution is about 1.4 L/kg. Serum protein binding averages15%. Metabolism: In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to less than 4% of the dose. Other metabolites are the S-oxide (1%) and the desmethyl ranitidine (1%). The remainder of the administered dose is found in the stool. Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant, alterations in ranitidine half-life, distribution, clearance, and bioavailability. Excretion: The principal route of excretion is the urine, with approximately 30% of the orally administered dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min, indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours. Four patients with clinically significant renal function impairment (creatinine clearance 25 to 35 mL/min) administered 50 mg of ranitidine intravenously had an average plasma half-life of 4.8 hours, a ranitidine clearance of 29 mL/min, and a volume of distribution of 1.76 L/kg. In general, these parameters appear to be altered in proportion to creatinine clearance (see DOSAGE AND ADMINISTRATION ). Geriatrics: The plasma half-life is prolonged and total clearance is reduced in the elderly population due to a decrease in renal function. The elimination half-life is 3 to 4 hours. Peak levels average 526 ng/mL following a 150-mg twice daily dose and occur in about 3 hours (see PRECAUTIONS: Geriatric Use: and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function:).

Pediatrics: There are no significant differences in the pharmacokinetic parameter values for ranitidine in pediatric patients (from 1 month up to 16 years of age) and healthy adults when correction is made for body weight. The average bioavailability of ranitidine given orally to pediatric patients is 48% which is comparable to the bioavailability of ranitidine in the adult population. All other pharmacokinetic parameter values (t1/2, Vd, and CL) are similar to those observed with intravenous ranitidine use in pediatric patients. Estimates of Cmax and Tmax are displayed in Table 1.

Table 1. Ranitidine Pharmacokinetics in Pediatric Patients Following Oral Dosing
Population (age) n Dosage Form (dose) Cmax (ng/mL) Tmax (hours)
Gastric or duodenal ulcer (3.5 to 16 years) 12 Tablets (1 to 2 mg/kg) 54 to 492 2.0

Pharmacodynamics: Serum concentrations necessary to inhibit 50% of stimulated gastric acid secretion are estimated to be 36 to 94 ng/mL. Following a single oral dose of 150 mg, serum concentrations of ranitidine are in this range up to 12 hours. However, blood levels bear no consistent relationship to dose or degree of acid inhibition. Antisecretory Activity: 1. Effects on Acid Secretion: Ranitidine inhibits both daytime and nocturnal basal gastric acid secretions as well as gastric acid secretion stimulated by food, betazole, and pentagastrin, as shown in Table 2.

Table 2. Effect of Oral Ranitidine on Gastric Acid Secretion
Time After Dose. hours % Inhibition of Gastric Acid Output by Dose, mg % Inhibition of Gastric Acid Output by Dose, mg % Inhibition of Gastric Acid Output by Dose, mg % Inhibition of Gastric Acid Output by Dose, mg
75 to 80 100 150 200
Basal Up to 4 99 95
Nocturnal Up to 13 95 96 92
Betazole Up to 3 97 99
Pentagastrin Up to 5 58 72 72 80
Meal Up to 3 73 79 95
Table 3. Duodenal Ulcer Patient healing Rates
Ranitidine* Ranitidine* Placebo* Placebo*
Number Entered Healed/Evaluable Number Entered Healed/Evaluable
Outpatients 195 69/182 (38%)† 188 31/164 (19%)
Week 2
Week 4 137/187 (73%)† 76/168 (45%)
*All patients were permitted antacids as needed for relief of pain. †p less than 0.0001. *All patients were permitted antacids as needed for relief of pain. †p less than 0.0001. *All patients were permitted antacids as needed for relief of pain. †p less than 0.0001. *All patients were permitted antacids as needed for relief of pain. †p less than 0.0001. *All patients were permitted antacids as needed for relief of pain. †p less than 0.0001.
Table 4. Mean Daily Doses of Antacid
Ulcer Healed Ulcer Not Healed
Ranitidine 0.06 0.71
Placebo 0.71 1.43
Table 5. Duodenal Ulcer Prevalence
Double-Blind, Multicenter, Placebo-Controlled Trials Double-Blind, Multicenter, Placebo-Controlled Trials Double-Blind, Multicenter, Placebo-Controlled Trials Double-Blind, Multicenter, Placebo-Controlled Trials Double-Blind, Multicenter, Placebo-Controlled Trials Double-Blind, Multicenter, Placebo-Controlled Trials
Multicenter trial Drug Duodenal Ulcer Prevalence Duodenal Ulcer Prevalence Duodenal Ulcer Prevalence No. of Patients
0 to 4 Months 0 to 8 Months 0 to 12 Months
USA RAN 20%* 24%* 35%* 138
PLC 44% 54% 59% 139
Foreign RAN 12%* 21%* 28%* 174
PLC 56% 64% 68% 165
% = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo % = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo % = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo % = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo % = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo % = Life table estimate. RAN = ranitidine (ranitidine tablets USP) PLC = placebo
*p less than 0.05 (ranitidine tablets USP versus comparator) *p less than 0.05 (ranitidine tablets USP versus comparator) *p less than 0.05 (ranitidine tablets USP versus comparator) *p less than 0.05 (ranitidine tablets USP versus comparator) *p less than 0.05 (ranitidine tablets USP versus comparator) *p less than 0.05 (ranitidine tablets USP versus comparator)
Table 6. Gastric Ulcer Patient Healing Rates
Ranitidine* Ranitidine* Placebo* Placebo*
Number Entered Healed/Evaluable Number Entered Healed/Evaluable
Outpatients 92 16/83 (19%) 94 10/83 (12%)
Week 2
Week 6 50/73 (68%)† 35/69 (51%)
*All patients were permitted antacids as needed for relief of pain. †p = 0.009. *All patients were permitted antacids as needed for relief of pain. †p = 0.009. *All patients were permitted antacids as needed for relief of pain. †p = 0.009. *All patients were permitted antacids as needed for relief of pain. †p = 0.009. *All patients were permitted antacids as needed for relief of pain. †p = 0.009.
Table 7. Erosive Esophagitis Healing Rates
Healed/Evaluable Healed/Evaluable
Placebo* n=229 Ranitidine 150 mg4 times daily.* n=215
Week 4 43/198 (22%) 96/206 (47%)†
Week 8 63/176 (36%) 142/200 (71%)†
Week 12 92/159 (8%) 162/192 (84%)†
*All patients were permitted antacid as neededs for relief of pain. †p less than 0.001 versus placebo. *All patients were permitted antacid as neededs for relief of pain. †p less than 0.001 versus placebo. *All patients were permitted antacid as neededs for relief of pain. †p less than 0.001 versus placebo.

INDICATIONS AND USAGE

Ranitidine tablets USP are indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year. 6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mgtwice dailyd. 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg4 times dailyd. 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks. Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.

CONTRAINDICATIONS Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS ).

PRECAUTIONS General: 1. Symptomatic response to therapy with ranitidine does not preclude the presence of gastric malignancy. 2. Since ranitidine is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION ). Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver. 3. Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute porphyria.

Laboratory Tests: False-positive tests for urine protein with MULTISTIX® may occur during ranitidine therapy, and therefore testing with sulfosalicylic acid is recommended.


Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg per day. Ranitidine was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays. In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.

Nursing Mothers: Ranitidine is secreted in human milk. Caution should be exercised when ranitidine is administered to a nursing mother.

Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of ranitidine in this age-group is supported by adequate and well-controlled studies in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature (see CLINICAL PHARMACOLOGY: Pediatrics: and DOSAGE AND ADMINISTRATION: Pediatric Use: ). Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established. Safety and effectiveness in neonates (less than 1 month of age) have not been established (see CLINICAL PHARMACOLOGY: Pediatrics:).

Geriatric Use: Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of ranitidine, for which there were subgroup analyses, 4,197 were 65 and over, while 899 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function. (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics: and DOSAGE AND ADMINISTRATION: Dosage Adjustment for Patients With Impaired Renal Function:).

ADVERSE REACTIONS The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine. Central Nervous System: Rarely, malaise, dizziness, somnolence, insomnia, and vertigo. Rare cases of reversible mental confusion, agitation, depression, and hallucinations have been reported, predominantly in severely ill elderly patients. Rare cases of reversible blurred vision suggestive of a change in accommodation have been reported. Rare reports of reversible involuntary motor disturbances have been received. Cardiovascular: As with other H2-blockers, rare reports of arrhythmias such as tachycardia, bradycardia, atrioventricular block, and premature ventricular beats.

Gastrointestinal: Constipation, diarrhea, nausea/vomiting, abdominal discomfort/pain, and rare reports of pancreatitis. Hepatic: There have been occasional reports of hepatocellular, cholestatic, or mixed hepatitis, with or without jaundice. In such circumstances, ranitidine should be immediately discontinued. These events are usually reversible, but in rare circumstances death has occurred. Rare cases of hepatic failure have also been reported. In normal volunteers, SGPT values were increased to at least twice the pretreatment levels in 6 of 12 subjects receiving 100 mg4 times daily foor 7 days, and in 4 of 24 subjects receiving 50 mg4 times dailyy for 5 days. Musculoskeletal: Rare reports of arthralgias and myalgias. Hematologic: Blood count changes (leukopenia, granulocytopenia, and thrombocytopenia) have occurred in a few patients. These were usually reversible. Rare cases of agranulocytosis, pancytopenia, sometimes with marrow hypoplasia, and aplastic anemia and exceedingly rare cases of acquired immune hemolytic anemia have been reported. Endocrine: Controlled studies in animals and man have shown no stimulation of any pituitary hormone by ranitidine and no antiandrogenic activity, and cimetidine-induced gynecomastia and impotence in hypersecretory patients have resolved when ranitidine has been substituted. However, occasional cases of gynecomastia, impotence, and loss of libido have been reported in male patients receiving ranitidine, but the incidence did not differ from that in the general population. Integumentary: Rash, including rare cases of erythema multiforme. Rare cases of alopecia and vasculitis. Respiratory: A large epidemiological study suggested an increased risk of developing pneumonia in current users of histamine-2-receptor antagonists (H2RAs) compared to patients who had stopped H2RA treatment, with an observed adjusted relative risk of 1.63 (95% Cl, 1.0 to -2.48). However, a causal relationship between use of H2RAs and pneumonia has not been established. Other: Rare cases of hypersensitivity reactions (e.g., bronchospasm, fever, rash, eosinophilia), anaphylaxis, angioneurotic edema acute interstitial nephritis,, and small increases in serum creatinine.

OVERDOSAGE There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS ). In addition, abnormalities of gait and hypotension have been reported. When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed. Studies in dogs receiving dosages of ranitidine in excess of 225 mg/kg per day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

Active Duodenal Ulcer: The current recommended adult oral dosage of ranitidine for duodenal ulcer is 150 mg twice daily. An alternative dosage of 300 mg once daily after the evening meal or at bedtime can be used for patients in whom dosing convenience is important. The advantages of one treatment regimen compared to the other in a particular patient population have yet to be demonstrated (see CLINICAL TRIALS: Active Duodenal Ulcer:). Smaller doses have been shown to be equally effective in inhibiting gastric acid secretion in US studies, and several foreign trials have shown that 100 mg twice daily is as effective as the 150-mg dose. Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics:). Maintenance of Healing of Duodenal Ulcers: The current recommended adult oral dosage is 150 mg at bedtime. Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome): The current recommended adult oral dosage is 150 mg twice a day. In some patients it may be necessary to administer ranitidine 150- mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease. Benign Gastric Ulcer: The current recommended adult oral dosage is 150 mg twice a day.

Maintenance of Healing of Gastric Ulcers: The current recommended adult oral dosage is 150 mg at bedtime. GERD: The current recommended adult oral dosage is 150 mg twice a day. Erosive Esophagitis: The current recommended adult oral dosage is 150 mg 4 times a day. Maintenance of Healing of Erosive Esophagitis: The current recommended adult oral dosage is 150 mg twice a day. Pediatric Use: The safety and effectiveness of ranitidine have been established in the age-group of 1 month to 16 years. There is insufficient information about the pharmacokinetics of ranitidine in neonatal patients (less than 1 month of age) to make dosing recommendations. The following 3 subsections provide dosing information for each of the pediatric indications. Treatment of Duodenal and Gastric Ulcers: The recommended oral dose for the treatment of active duodenal and gastric ulcers is 2 to 4 mg/kg twice daily to a maximum of 300 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Maintenance of Healing of Duodenal and Gastric Ulcers: The recommended oral dose for the maintenance of healing of duodenal and gastric ulcers is 2 to 4 mg/kg once daily to a maximum of 150 mg/day. This recommendation is derived from adult clinical studies and pharmacokinetic data in pediatric patients. Treatment of GERD and Erosive Esophagitis: Although limited data exist for these conditions in pediatric patients, published literature supports a dosage of 5 to 10 mg/kg per day, usually given as 2 divided doses. Dosage Adjustment for Patients With Impaired Renal Function: On the basis of experience with a group of subjects with severely impaired renal function treated with ranitidine, the recommended dosage in patients with a creatinine clearance less than50 mL/min is 150 mg every 24 hours. Should the patient’s condition require, the frequency of dosing may be increased to every 12 hours or even further with caution. Hemodialysis reduces the level of circulating ranitidine. Ideally, the dosing schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis. Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLGOY: Pharmacokinetics: Geriatrics: and PRECAUTIONS: Geriatric Use: ).

HOW SUPPLIED Ranitidine tablets USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side and “150” on the other side. They are available in bottles of 60 (NDC 68462-248-60), 100 (NDC 68462-248-01), and 500 (NDC 68462-248-05) tablets. Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with “G51” engraved on one side and “300” on the other side. They are available in bottles of 30 (NDC 68462-249-30) and 100 (NDC 68462-249-01) tablets and 250 (NDC 68462-249-20) tablets. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15 o to 30 o C (59 o to 86 o F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening. Manufactured by: Shasun Chemicals and Drugs Limited, Unit-II, R.S. No. 32, 33 and 34, PIMS Road, Periyakalapet, Pondicherry - 605 014. India. Manufactured for: G Glenmark Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkgenerics.com April 2009

G

Glenmark

NDC 68468-248-01

RANITIDINE TABLETS USP

150 mg

Rx Only    100 Tablets

Each tablet contains 150 mg of ranitidine as ranitidine hydrochloride USP.

See package insert for Dosage and Administration.

Store at 20 Degree to 25 Degree C (59 Degree to 77 Degree F): excursions permitted to 15 Degree to 30 Degree C (59 Degree to 86 Degree F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.  

For the Dietary Management of Sleep Disorders.

Two capsules at bedtime or as directed by physician. See product label and insert.

Sentra PM Medical Food

A Convenlence Packed Medical Food And Drug

Sentradine

PHYSICIAN THERAPEUTICS

> Sentra PM 60 Capsules > Ranitidine 150 mg 30 Tablets

No Refills Without Physician Authorization

Rx only

NDC# 68405-8033-26 of this co-pack

FRONT VIEW

As prescribed by physician. See  product  label and  product information insert.

Ranitidine 150 mg Rx Drug

BACK VIEW

Physician Therapeutics LLC Los Angeles, CA 90077  on November 21, 2006

Ranitidine Inner

Ranitidine Outer


SENTRADINE 
ranitidine hydrochloride   tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68405-033 (68462-248)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
FD&C RED NO. 40  
HYPROMELLOSES  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color pink (PINK) Score no score
Shape ROUND Size 13mm
Flavor Imprint Code G51;300
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68405-033-26 1 BOTTLE In 1 PACKAGE contains a BOTTLE
1 30 TABLET In 1 BOTTLE This package is contained within the PACKAGE (68405-033-26)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/13/2010

Labeler - Physician Therapeutics LLC (931940964)
Establishment
Name Address ID/FEI Operations
Shasun Chemicals 915786829 manufacture
Establishment
Name Address ID/FEI Operations
Pharma Pac 147681894 repack
Revised: 10/2010 Physician Therapeutics LLC