CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE- ciprofloxacin and fluocinolone acetonide solution 
Wilshire Pharmaceuticals

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Ciprofloxacin and Fluocinolone Acetonide Otic Solution safely and effectively. See full prescribing information for Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

Ciprofloxacin and Fluocinolone Acetonide otic solution

Initial U.S. Approval: 2016

INDICATIONS AND USAGE

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is a combination of ciprofloxacin, a fluoroquinolone antibacterial, and fluocinolone acetonide, a corticosteroid, indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa (1)

DOSAGE AND ADMINISTRATION

  • Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic administration only. It is not for ophthalmic use, or for injection. (2)
  • Instill the contents of one single-dose vial (0.25 mL) into the affected ear canal twice daily for 7 days. (2)
  • Use this dosing regimen for patients aged 6 months and older. (2)

DOSAGE FORMS AND STRENGTHS

Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg. (3)

CONTRAINDICATIONS

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is contraindicated in:

  • Patients with known hypersensitivity to fluocinolone acetonide or other corticosteroids, ciprofloxacin or other quinolones, or to any component of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. (4)
  • Viral infections of the external ear canal, including varicella and herpes simplex infections and fungal otic infections. (4)

WARNINGS AND PRECAUTIONS

  • Hypersensitivity: Discontinue use at the first appearance of a skin rash or any other sign of hypersensitivity. (5.1)
  • Potential for Microbial Overgrowth: Prolonged use may result in the overgrowth of non-susceptible bacteria and fungi. If such infections occur, discontinue use and institute alternative therapy. (5.2)

ADVERSE REACTIONS

The most common adverse reactions that occurred in ≥1 patient were otorrhea, excessive granulation tissue, ear infection, ear pruritus, tympanic membrane disorder, auricular swelling and balance disorder (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 5/2019

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Potential for Microbial Overgrowth with Prolonged Use

5.3 Continued or Recurrent Otorrhea

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT) in pediatric patients (aged 6 months and older) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa.

2 DOSAGE AND ADMINISTRATION

The recommended dosage regimen is as follows:

3 DOSAGE FORMS AND STRENGTHS

Otic Solution: Each single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution (ciprofloxacin 0.3 % and fluocinolone acetonide 0.025 %) delivers 0.25 mL of solution equivalent to ciprofloxacin 0.75 mg and fluocinolone acetonide 0.0625 mg.

4 CONTRAINDICATIONS

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is contraindicated in:

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Ciprofloxacin and Fluocinolone Acetonide Otic Solution should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria and itching. Serious acute hypersensitivity reactions may require immediate emergency treatment.

5.2 Potential for Microbial Overgrowth with Prolonged Use

Prolonged use of Ciprofloxacin and Fluocinolone Acetonide Otic Solution may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

5.3 Continued or Recurrent Otorrhea

If otorrhea persists after a full course of therapy, or if two or more episodes of otorrhea occur within 6 months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 224 patients with AOMT were treated with Ciprofloxacin and Fluocinolone Acetonide Otic Solution for a median duration of 7 days. All the patients received at least one dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. There were 220 patients who received at least one dose of ciprofloxacin (CIPRO) and 213 patients received at least one dose of fluocinolone acetonide (FLUO).

The most common adverse reactions that occurred in 1 or more patients are as follows:

Table 1: Selected Adverse Reactions that Occurred in 1 or more Patients in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution Group
Adverse Reactions*Number (%) of Patients
Ciprofloxacin and Fluocinolone Acetonide Otic Solution
N=224
CIPRO
N=220
FLUO
N=213
*
Selected adverse reactions that occurred in ≥ 1 patient in the Ciprofloxacin and Fluocinolone Acetonide Otic Solution group derived from all reported adverse events that could be related to the study drug or the drug class.
Otorrhea12 (5.4%)9 (4.1%)12 (5.6%)
Excessive granulation tissue3 (1.3%)0 (0.0%)2 (0.9%)
Ear infection2 (0.9%)3 (1.4%)1 (0.5%)
Ear pruritus2 (0.9%)1 (0.5%)1 (0.5%)
Tympanic membrane disorder2 (0.9%)0 (0.0%)0 (0.0%)
Auricular swelling1 (0.4%)1 (0.5%)0 (0.0%)
Balance disorder1 (0.4%)0 (0.0%)0 (0.0%)

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of ciprofloxacin and fluocinolone acetonide otic solution, 0.3% / 0.025% outside the US. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Immune system disorders: allergic reaction.
  • Infections and infestations: candidiasis.
  • Nervous system disorders: dysgeusia, paresthesia (tingling in ears), dizziness, headache.
  • Ear and labyrinth disorders: ear discomfort, hypoacusis, tinnitus, ear congestion.
  • Vascular disorders: flushing.
  • Skin and subcutaneous tissue disorders: skin exfoliation.
  • Injury, poisoning and procedural complications: device occlusion (tympanostomy tube obstruction).

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed following otic administration and maternal use is not expected to result in fetal exposure to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3)].

8.2 Lactation

Risk Summary

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is negligibly absorbed by the mother following otic administration and breastfeeding is not expected to result in exposure of the infant to ciprofloxacin and fluocinolone acetonide [see Clinical Pharmacology (12.3)].

8.4 Pediatric Use

Ciprofloxacin and Fluocinolone Acetonide Otic Solution has been studied in patients as young as 6 months in adequate and well-controlled clinical trials. No major differences in safety and effectiveness have been observed between adult and pediatric patients [see Indications and Usage (1) and Dosage and Administration (2)].

8.5 Geriatric Use

Clinical studies of Ciprofloxacin and Fluocinolone Acetonide Otic Solution did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

10 OVERDOSAGE

Due to the characteristics of this preparation, no toxic effects are to be expected with an otic overdose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution.

11 DESCRIPTION

Ciprofloxacin and Fluocinolone Acetonide Otic Solution, 0.3% / 0.025% is a sterile, preservative-free, clear otic solution containing the fluoroquinolone antibacterial, ciprofloxacin hydrochloride, combined with the corticosteroid, fluocinolone acetonide. Each single-dose vial contains a deliverable volume of 0.25 mL solution of ciprofloxacin hydrochloride equivalent to 0.75 mg ciprofloxacin and 0.0625 mg fluocinolone acetonide. The pH of the solution ranges from 3.5 to 5.0. The inactive ingredients are polysorbate 80, glycerin, povidone K90F and water for injection.

Ciprofloxacin is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3∙HCl∙H2O.

The chemical structure of ciprofloxacin hydrochloride is:

Chemical Structure

The chemical name of fluocinolone acetonide is (6α,11β,16α)-6,9-difluoro-11,21-dihydroxy- 16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone[67-73-2]. Its molecular formula is C24H30F2O6.

The chemical structure of fluocinolone acetonide is:

Chemical Structure

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ciprofloxacin is a fluoroquinolone antibacterial [see Microbiology (12.4)].

Fluocinolone acetonide, a corticosteroid, inhibits the local biosynthesis of prostaglandins, which explains part of its anti-inflammatory efficacy. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system.

12.3 Pharmacokinetics

In two studies in children with AOMT aged ≥ 6 months to 12 years, blood samples were taken in subgroups of 16 and 14 patients, at Visit 1 (prior to the first dose) and Visit 3 (within 1 and 2 hours after the last dose) respectively, to determine the plasma concentrations of ciprofloxacin and/or fluocinolone acetonide following administration of Ciprofloxacin and Fluocinolone Acetonide Otic Solution at the recommended dosage regimen of 0.25 mL twice daily. Pharmacokinetic (PK) analysis resulted in only 1 sample showing a detectable concentration of ciprofloxacin in plasma of 3.0 mcg/L after 7 days of treatment, and no detectable concentrations in plasma of fluocinolone acetonide were observed. However, the sample with detectable ciprofloxacin concentrations was from a patient who had bilateral AOMT (protocol deviation because all patients participating in the PK study were to have unilateral otorrhea) and who received treatment in both ears with ciprofloxacin 0.3% otic solution, the active comparator.

12.4 Microbiology

Mechanism of Action

The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA.

Resistance

Bacterial resistance to quinolones can develop through chromosomal or plasmid-mediated mechanisms.

In vitro studies demonstrated cross-resistance between ciprofloxacin and some fluoroquinolones. There is generally no cross-resistance between ciprofloxacin and other classes of antibacterial agents such as beta-lactams or aminoglycosides.

Antimicrobial Activity

Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and clinically in otic infections [see Indications and Usage (1)]:

Aerobic Bacteria:

Gram-positive Bacteria:
Staphylococcus aureus
Streptococcus pneumoniae

Gram-negative Bacteria:
Pseudomonas aeruginosa
Haemophilus influenzae
Moraxella catarrhalis

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

No long term studies of Ciprofloxacin and Fluocinolone Acetonide Otic Solution have been performed to evaluate carcinogenic potential.

Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of fluocinolone acetonide.

Mutagenesis

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:

  • Salmonella/Microsome Test (Negative)
  • E. coli DNA Repair Assay (Negative)
  • Mouse Lymphoma Cell Forward Mutation Assay (Positive)
  • Chinese Hamster V79 Cell HGPRT Test (Negative)
  • Syrian Hamster Embryo Cell Transformation Assay (Negative)
  • Saccharomyces cerevisiae Point Mutation Assay (Negative)
  • Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
  • Rat Hepatocyte DNA Repair Assay (Positive)

Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:

  • Rat Hepatocyte DNA Repair Assay
  • Micronucleus Test (Mice)
  • Dominant Lethal Test (Mice)

Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide. Some corticosteroids have been found to be genotoxic.

Impairment of Fertility

No reproduction toxicity studies were conducted with Ciprofloxacin and Fluocinolone Acetonide Otic Solution. Absorption of ciprofloxacin and fluocinolone acetonide following otic administration of Ciprofloxacin and Fluocinolone Acetonide Otic Solution at the recommended dosage is negligible [see Clinical Pharmacology (12.3)].

14 CLINICAL STUDIES

Two phase 3 multicenter, randomized, double-blind, active-controlled, parallel group trials were conducted in 662 pediatric patients in total (aged 6 months to 12 years old) with AOMT, to assess the efficacy and safety of Ciprofloxacin and Fluocinolone Acetonide Otic Solution compared to ciprofloxacin otic solution and to fluocinolone acetonide otic solution (Trial 1 and Trial 2).

In both trials, the Ciprofloxacin and Fluocinolone Acetonide Otic Solution treatment arms showed significantly shorter times to cessation of otorrhea in comparison to both the ciprofloxacin and fluocinolone acetonide alone arms demonstrating the contribution of both components of Ciprofloxacin and Fluocinolone Acetonide Otic Solution. The results are presented in the table below:

Table 2: Results of the Primary Endpoint: Time to Cessation of Otorrhea (Trial 1 and Trial 2)
Treatment arm
n.e.: not estimable because the number of censored patients was greater than the number of patients with cessation of otorrhea
*
Kaplan-Meier median estimate censored all subjects who did not have a cessation of otorrhea at the maximum time point of 22 days.
Log-rank test stratified by age (patients younger than 3 years versus 3 years and older)
Trial 1Ciprofloxacin and Fluocinolone Acetonide Otic Solution
(N=112)
CIPRO
(N=109)
FLUO
(N=110)
Number (%) with cessation of otorrhea by Day 2288 (78.6%)73 (67.0%)53 (48.2%)
Median time to cessation* (days)3.757.69n.e.
p-value vs Ciprofloxacin and Fluocinolone Acetonide Otic Solution<0.001<0.001
 
Trial 2Ciprofloxacin and Fluocinolone Acetonide Otic Solution
(N=111)
CIPRO
(N=112)
FLUO
(N=108)
Number (%) with cessation of otorrhea by Day 2287 (78.4%)77 (68.8%)47 (43.5%)
Median time to cessation* (days)4.946.83n.e.
p-value vs Ciprofloxacin and Fluocinolone Acetonide Otic Solution0.028<0.001

16 HOW SUPPLIED/STORAGE AND HANDLING

How supplied

Ciprofloxacin and Fluocinolone Acetonide Otic Solution, 0.3 %/0.025 %, is a sterile, preservative-free, clear otic solution supplied in blue translucent single-dose 0.25 mL vials. Fourteen single-dose vials are packaged in a protective foil pouch contained in a carton (NDC 52536-080-14).

Storage

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from light; store unused vials in pouch and discard 7 days after opening the pouch. Do not open until ready to use. Discard vial after use.

17 PATIENT COUNSELING INFORMATION

Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Administration Instructions

  • Advise patients that Ciprofloxacin and Fluocinolone Acetonide Otic Solution is for otic use only. It is not to be used in the eyes.
  • Advise patients to warm the otic solution by holding the vial in the hand for 1 to 2 minutes before instilling it in the ear, to avoid dizziness.

Hypersensitivity Reactions

  • Advise patients to immediately discontinue Ciprofloxacin and Fluocinolone Acetonide Otic Solution at the first appearance of a skin rash or any other sign of hypersensitivity [see Warnings and Precautions (5.1)]

Ciprofloxacin and Fluocinolone Acetonide Otic Solution is:

Distributed by:
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

Under license of Laboratorios SALVAT, S.A.

U.S. Patent No: 8,932,610

OTO-PIAG-00

INSTRUCTIONS FOR USE
CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE
(sip-roh-flok-suh-sin and floo-oh-SIN-oh-lone uh-SEET-oh-nide)
Otic Solution

Read this Instructions for Use that comes with Ciprofloxacin and Fluocinolone Acetonide Otic Solution before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Important information about Ciprofloxacin and Fluocinolone Acetonide Otic Solution:

How should I use Ciprofloxacin and Fluocinolone Acetonide Otic Solution?

Step 1.You or your caregiver should wash their hands with soap and water.Image
Step 2.Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any other object in the ear canal.Image
Step 3.Remove Ciprofloxacin and Fluocinolone Acetonide Otic Solution from the protective foil pouch. Pull apart 1 single-dose vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution as shown, by tearing along the dotted lines (perforations) until it is fully separated.Image
Step 4.Warm the dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution by holding the vial in your hand for 1 to 2 minutes.Image
Step 5.Twist off the vial cap in the direction of the arrow as shown.Image
Step 6.The person receiving Ciprofloxacin and Fluocinolone Acetonide Otic Solution should be on his/her side with the infected ear up as shown. Image
Step 7.Hold the vial of Ciprofloxacin and Fluocinolone Acetonide Otic Solution in your hand and place the vial close to the ear. Let the entire dose of Ciprofloxacin and Fluocinolone Acetonide Otic Solution fall into the affected ear.Image
Step 8.Gently press the part of the ear known as the tragus 4 times using a pumping motion as shown. This will allow the drops of Ciprofloxacin and Fluocinolone Acetonide Otic Solution to enter the middle ear.Image
Step 9.Remain on your side with the affected ear facing upward for 1 minute.Image
Step 10.If your healthcare provider has told you to use Ciprofloxacin and Fluocinolone Acetonide Otic Solution in both ears, repeat Steps 2-9 for the other ear.
Step 11.Safely throw away Ciprofloxacin and Fluocinolone Acetonide Otic Solution vials after use.

This Instructions for Use has been approved by the Food and Drug Administration.

Rev. 05/2019

PRINCIPAL DISPLAY PANEL - 0.25 mL Vial Pouch Carton

NDC 52536-080-14
Rx Only

Ciprofloxacin 0.3% and
Fluocinolone Acetonide 0.025%

Otic solution

Sterile
Preservative-free

FOR USE IN THE EAR ONLY

Contents:
14 vials
0.25 mL each
(Deliverable volume)

WILSHIRE®
PHARMACEUTICALS, INC

Salvat

PRINCIPAL DISPLAY PANEL - 0.25 mL Vial Pouch Carton
CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE 
ciprofloxacin and fluocinolone acetonide solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52536-080
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ciprofloxacin (UNII: 5E8K9I0O4U) (ciprofloxacin - UNII:5E8K9I0O4U) ciprofloxacin0.75 mg  in 0.25 mL
fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M) fluocinolone acetonide0.0625 mg  in 0.25 mL
Inactive Ingredients
Ingredient NameStrength
glycerin (UNII: PDC6A3C0OX)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
povidone K90 (UNII: RDH86HJV5Z)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52536-080-141 in 1 CARTON11/01/2019
114 in 1 POUCH
10.25 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20825111/01/2019
Labeler - Wilshire Pharmaceuticals (078657245)
Establishment
NameAddressID/FEIBusiness Operations
The Ritedose Corporation837769546MANUFACTURE(52536-080) , PACK(52536-080)

Revised: 10/2019
Document Id: 902d710e-3983-4f9b-b8eb-4a990bc4efa8
Set id: 7841d7d6-e950-4956-a0a2-4381c90cfe34
Version: 1
Effective Time: 20191022
 
Wilshire Pharmaceuticals