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Generated: November 12, 2018

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Details for New Drug Application (NDA): 091327

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NDA 091327 describes CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, which is a drug marketed by Actavis Mid Atlantic, Amneal Pharms, Apnar Pharma Lp, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Cypress Pharm, Lannett Co Inc, Perrigo R And D, Ranbaxy Labs Ltd, Taro, Tris Pharma Inc, Jubilant Generics, and Sun Pharma Global, and is included in fifteen NDAs. It is available from forty-five suppliers. Additional details are available on the CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF profile page.

The generic ingredient in CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF is cetirizine hydrochloride. There are thirty-nine drug master file entries for this compound. One hundred and sixty-one suppliers are listed for this compound. Additional details are available on the cetirizine hydrochloride profile page.
Summary for 091327
Tradename:CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Applicant:Apnar Pharma Lp
Ingredient:cetirizine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091327
Suppliers and Packaging for NDA: 091327
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 091327 ANDA Caraco Pharmaceutical Laboratories, Ltd 57664-246 57664-246-31 120 mL in 1 BOTTLE (57664-246-31)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY cetirizine hydrochloride SYRUP;ORAL 091327 ANDA Caraco Pharmaceutical Laboratories, Ltd 57664-246 57664-246-34 470 mL in 1 BOTTLE (57664-246-34)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Oct 17, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SYRUP;ORALStrength5MG/5ML
Approval Date:Oct 17, 2011TE:RLD:No

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