Label: PROFENDER (2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino- 2,1-aisoquinolin-4-one, emodepside solution
PROFENDER (2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino- 2,1-aisoquinolin-4-one, emodepside kit
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NDC Code(s):
58198-0059-1,
58198-0059-2,
58198-0059-3,
58198-0060-1, view more58198-0060-2, 58198-0060-3, 58198-0061-1, 58198-0061-2, 58198-0061-3, 58198-0062-1
- Packager: Elanco US Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated May 25, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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DESCRIPTION:
PROFENDER [1.98% emodepside/7.94% praziquantel] Topical Solution is a clear yellow ready-to-use solution packaged in single unit dosing applicator tubes for topical (dermal) treatment of cats 8 weeks of age and older and weighing at least 2.2 lbs (1 kg). The formulation and dosage schedule is designed to provide a minimum of 1.36 mg/lb (3 mg/kg) emodepside and 5.45 mg/lb (12 mg/kg) praziquantel based on body weight. Emodepside, a semi-synthetic molecule, is a cyclic depsipeptide. The chemical name is Cyclo [D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl-D-2-hydroxypropanoyl-N-methyl-L-leucyl-3-[4-(4-morpholinyl)phenyl]-D-2-hydroxypropanoyl-N-methyl-L-leucyl]. Praziquantel is an isoquinoline cestocide. The chemical name is 2-Cyclohexylcarbonyl-1,2,3,6,7,11b-hexahydro-4H-pyrazine-2,1-a-iso-quinoline-4-one.
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INDICATIONS:
PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.
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DOSAGE AND ADMINISTRATION:
The recommended minimum dose is 1.36 mg/lb (3 mg/kg) emodepside + 5.45 mg/lb (12 mg/kg) praziquantel as a single topical dose. A single treatment is effective and a second treatment should not be necessary. If re-infection occurs, the product can be re-applied after 30 days.
- 1.
- Select the package that correctly corresponds with the body weight of the cat. (See Table below.)
* Cats over 17.6 lbs should be treated with the appropriate combination of tubes. Cat Weight*
Profender Topical Solution
Volume (mL)
Emodepside (mg)
Praziquantel (mg)
2.2-5.5 lbs.
Small
0.35
7.5
30.0
>5.5-11 lbs.
Medium
0.70
15.0
60.1
>11-17.6 lbs.
Large
1.12
24.0
96.1
- 2.
- Remove one unit dose tube from the package.
- 3.
- While holding the tube in an upright position, remove the cap from the tube.
- 4.
- Turn the cap over and place the other end of cap onto the tip of the tube.
- 5.
- Twist the cap to break the seal and then remove cap from the tube.
- 6.
- Part the hair on the back of the cat’s neck at the base of the head, until the skin is visible.
- 7.
- The ensure the entire contents of the tube are administered, place the tip of the tube on the skin and squeeze the entire contents directly onto the skin. Lift tube away from the skin before releasing pressure on the tube.
Do not apply to broken skin or if hair coat is wet. Do not get this product in the cat’s mouth or eyes or allow the cat to lick the application site for one hour. Oral exposure can cause salivation and vomiting. Treatment at the base of the head will minimize the opportunity for ingestion while grooming. In households with multiple pets, keep animals separated to prevent licking of the application site.
Stiff hair, a damp appearance of the hair, or a slight powdery residue may be observed at the treatment site. These effects are temporary and do not affect the safety or effectiveness of the product.
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HUMAN WARNINGS:
Not for human use. Keep out of reach of children.
To prevent accidental ingestion of the product, children should not come in contact with the application site for twenty-four (24) hours while the product is being absorbed. Pregnant women, or women who may become pregnant, should avoid direct contact with, or wear disposable gloves when applying, this product. Studies performed in rats and rabbits suggest that emodepside may interfere with fetal development in those species.
PROFENDER Topical Solution may be irritating to skin and eyes. Reactions such as facial, tongue and hand swelling have been reported in humans in rare instances. Avoid contact with the application area while it is wet and wash hands thoroughly with soap and warm water after handling. People with known hypersensitivity to butylhydroxyanisole, emodepside or praziquantel should administer the product with caution. If the product accidentally gets into eyes, flush thoroughly with water. May be harmful if swallowed. In case of accidental ingestion or if skin or eye irritation occurs, call a poison control center or physician for treatment advice.
The Safety Data Sheet (SDS) provides additional occupational safety information. For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973.
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PRECAUTIONS:
Safe use of this product has not been evaluated in cats less than 8 weeks of age or weighing less than 2.2 lbs (1 kg), in cats used for breeding, during pregnancy or in lactating queens. The effectiveness of this product when used before bathing has not been evaluated.
Use with caution in sick or debilitated cats. Oral ingestion or exposure should be avoided. Use with caution in heartworm positive cats. The cats enrolled in the field study were heartworm antigen and antibody negative prior to entering the study. In a laboratory study, cats artificially infected with adult heartworms and treated with PROFENDER Topical Solution had fewer worms recovered than the placebo control group. (See ANIMAL SAFETY.)
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ADVERSE REACTIONS:
Field study: In a controlled, double-masked field safety study, owners administered PROFENDER Topical Solution to 606 cats. Adverse reactions reported by the cat owners included licking/excessive grooming in 18 cats (3.0%), scratching treatment site in 15 cats (2.5%), salivation in 10 cats (1.7%), lethargy in 10 cats (1.7%), alopecia in 8 cats (1.3%), agitation/nervousness in 7 cats (1.2%), vomiting in 6 cats (1.0%), diarrhea in 3 cats (0.5%), eye irritation in 3 cats (0.5%), respiratory irritation in 1 cat (0.2%) and shaking/tremors in 1 cat (0.2%). All adverse reactions were self-limiting.
Laboratory effectiveness studies: One cat died 10 days after receiving PROFENDER Topical Solution. The necropsy showed chronic active cholangiohepatitis. While the use of the drug did not appear to be the direct cause of death, treatment with the drug cannot be ruled out as a contributing factor (See PRECAUTIONS). One cat treated with a vehicle placebo (formulation minus the active ingredients) showed salivation, gagging, lethargy and a swollen tongue.
Foreign Market Experience: The following adverse events were reported voluntarily during post-approval use of the product in foreign markets: application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), salivation, pruritus, lethargy, vomiting, diarrhea, dehydration, ataxia, loss of appetite, facial swelling, rear leg paresis, seizures, hyperesthesia, twitching, and death.
Post-Approval Experience: The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data. The following adverse events are listed in decreasing order of reporting frequency in cats: Application site reaction (hair loss, dermatitis, pyoderma, edema, and erythema), hypersalivation, lethargy/depression, vomiting, ataxia, anorexia, trembling/twitching, diarrhea, mydriasis, fever, hyper-activity/nervousness. In some cases, death has been reported as an outcome of the adverse events listed. For a complete listing of the adverse reactions for Profender Topical Solution reported to the CVM see http://www.fda.gov/ADEreports.
This listing includes Adverse Events reported to CVM for products, such as Profender, that contain the combined active ingredients emodepside and praziquantel. Listings by active ingredient may represent more than one brand name.
For product questions, to report adverse reactions, or for a copy of the Safety Data Sheet (SDS), call Elanco Product & Veterinary Support at 888-545-5973. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
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EFFECTIVENESS:
In a total of 13 controlled laboratory studies to establish effectiveness, 149 cats were treated with PROFENDER Topical Solution. In the field study conducted at 13 veterinary clinics/hospitals, 837 purebred or crossbred cats from single and multi-cat households were enrolled to evaluate safety and effectiveness under field conditions of use. Of those, 606 received a single treatment with PROFENDER Topical Solution. Cats ranged in age between 2 months and 17 years and weighed between 0.8 lbs (0.36 kg) and 21 lbs (9.62 kg). Data from these studies demonstrated PROFENDER Topical Solution is safe and effective for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults).
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ANIMAL SAFETY:
In a field study, PROFENDER Topical Solution was used in cats receiving other frequently used products including: analgesics, anti-fungals, nonsteroidal anti-inflammatories, anthelmintics, antimicrobials, flea and tick products, sedatives, anesthetics, cardiac medications, anxiolytics, hormonal treatments, steroids, otic and ophthalmic preparations, and vaccines.
Dose Tolerance Study in Cats: PROFENDER Topical Solution was applied topically one time to young cats at 10X the recommended label use rate. Two cats salivated. Another cat exhibited tremors and lethargy. These signs were self-limiting.
Oral Safety Studies in Cats: PROFENDER Topical Solution was administered orally at the recommended topical dose to young adult cats. The cats exhibited salivation, vomiting, tremors, abnormal gait, abnormal respiration and weight loss. These signs were self-limiting.
General Safety Study in Kittens: PROFENDER Topical Solution was topically applied at 0X (vehicle control), 1X, 3X and 5X the maximum dose to 48 healthy 8-week-old kittens every two weeks for six doses. One 5X kitten experienced salivation and tremors and another 5X kitten experienced salivation on the day of dosing. A third 5X kitten experienced tremors the day after dosing. Three cats vomited within 24 hours of dosing, one each in vehicle control, 3X and 5X groups.
Safety Study in Heartworm Positive Cats: Cats artificially infected with adult heartworms harvested from dogs were treated topically with PROFENDER Topical Solution at 0X, 1X or 5X the recommended dose once a month for three treatments. Clinical signs included salivation (one 1X and three 5X cats), labored breathing (all groups) and lethargy (one 5X cat). At the study conclusion, the 1X and 5X cats had fewer live heartworms recovered than the 0X group.
- STORAGE INFORMATION:
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HOW SUPPLIED:
Made in GermanyApproved by FDA under NADA # 141-275
Manufactured for:
Elanco US Inc.
Greenfield, IN 46140 U.S.A
©2022 Elanco or its affiliates.Profender, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
Revised: May 2022
ElancoTM -
Principal Display Panel - 0.35 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Small
For Cats and Kittens
8 weeks of age and older and weighing at least 2.2-5.5 lbs.
Contains 40 - 0.35 ml tubes
40 tubes
Each tube contains 7.5 mg of emodepside and 30 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 0.35 mL Blister Pack Label
- Principal Display Panel - 0.35 mL Tube Label
-
Principal Display Panel - 0.70 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Medium
For Cats and Kittens
8 weeks of age and older and weighing > 5.5 - 11 lbs.
Contains 40 - 0.70 ml tubes
40 tubes
Each tube contains 15 mg of emodepside and 60.1 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 0.70 mL Blister Pack Label
- Principal Display Panel - 0.70 mL Tube Label
-
Principal Display Panel - 1.12 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Large
For Cats and Kittens
8 weeks of age and older and weighing > 11 – 17.6 lbs.
Contains 40 – 1.12 ml tubes
40 tubes
Each tube contains 24 mg of emodepside and 96.1 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 1.12 mL Blister Pack Label
- Principal Display Panel - 1.12 mL Tube Label
-
Principal Display Panel - 0.35 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Small
For Cats and Kittens
8 weeks of age and older and weighing at least 2.2-5.5 lbs.
Contains 20 - 0.35 ml tubes
20 tubes
Each tube contains 7.5 mg of emodepside and 30 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 0.35 mL Blister Pack Label
- Principal Display Panel - 0.35 mL Tube Label
-
Principal Display Panel - 0.70 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Medium
For Cats and Kittens
8 weeks of age and older and weighing > 5.5 - 11 lbs.
Contains 20 - 0.70 ml tubes
20 tubes
Each tube contains 15 mg of emodepside and 60.1 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 0.70 mL Blister Pack Label
- Principal Display Panel - 0.70 mL Tube Label
-
Principal Display Panel - 1.12 mL Carton Label
convenient, easy to apply
Topical Solution
profender™
(emodepside/praziquantel)
CAUTION: Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Topical Solution for the treatment and control of hookworm, roundworm and tapeworm infections.
Large
For Cats and Kittens
8 weeks of age and older and weighing > 11 – 17.6 lbs.
Contains 20 – 1.12 ml tubes
20 tubes
Each tube contains 24 mg of emodepside and 96.1 mg of praziquantel.
Approved by FDA under NADA# 141-275
Elanco™
- Principal Display Panel - 1.12 mL Blister Pack Label
- Principal Display Panel - 1.12 mL Tube Label
-
Principal Display Panel - Kit Label
Elanco™
Topical Solution
profender™
(emodepside/praziquantel)
8
tubesSmall
For Cats and Kittens
8 weeks of age and older and weighing > 2.2-5.5 lbs
Contains 8 - 0.35 ml tubes
Each tube contains 7.5 mg of emodepside and 30 mg of praziquantel.
20
tubesMedium
For Cats and Kittens
8 weeks of age and older and weighing > 5.5-11 lbs
Contains 20 - 0.70 ml tubes
Each tube contains 15 mg of emodepside and 60.1 mg of praziquantel.
8
tubesLarge
For Cats and Kittens
8 weeks of age and older and weighing > 11-17.6 lbs
Contains 8 - 1.12 ml tubes
Each tube contains 24 mg of emodepside and 96.1 mg of praziquantel.
See package insert for complete product information.
- Principal Display Panel - 0.35 mL Tube Label
- Principal Display Panel - 0.70 mL Tube Label
- Principal Display Panel - 1.12 mL Tube Label
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INGREDIENTS AND APPEARANCE
PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0059-1 10 in 1 BOX 1 4 in 1 BLISTER PACK 1 NDC:58198-0059-2 0.35 mL in 1 TUBE 2 NDC:58198-0059-3 5 in 1 BOX 2 NDC:58198-0059-2 0.35 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 06/29/2007 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0060-1 10 in 1 BOX 1 4 in 1 BLISTER PACK 1 NDC:58198-0060-2 0.7 mL in 1 TUBE 2 NDC:58198-0060-3 5 in 1 BOX 2 NDC:58198-0060-2 0.7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 06/29/2007 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0061 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0061-1 10 in 1 BOX 1 4 in 1 BLISTER PACK 1 NDC:58198-0061-2 1.12 mL in 1 TUBE 2 NDC:58198-0061-3 5 in 1 BOX 2 NDC:58198-0061-2 1.12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 06/29/2007 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside kitProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-0062 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0062-1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 TUBE 2.8 mL Part 2 20 TUBE 14 mL Part 3 8 TUBE 8.96 mL Part 1 of 3 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BOX 1 1 in 1 BLISTER PACK 1 0.35 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 12/21/2015 Part 2 of 3 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 5 in 1 BOX 1 4 in 1 BLISTER PACK 1 0.7 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 12/21/2015 Part 3 of 3 PROFENDER
2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4h-pyrazino(2,1-a)isoquinolin-4-one, emodepside solutionProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAZIQUANTEL (UNII: 6490C9U457) (PRAZIQUANTEL - UNII:6490C9U457) PRAZIQUANTEL 30 mg in 0.35 mL EMODEPSIDE (UNII: YZ647Y5GC9) (EMODEPSIDE - UNII:YZ647Y5GC9) EMODEPSIDE 7.5 mg in 0.35 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BOX 1 4 in 1 BLISTER PACK 1 1.12 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 12/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141275 12/21/2015 Labeler - Elanco US Inc. (966985624)
