DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 091327
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.
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: | OTC | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 17, 2011 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SYRUP;ORAL | Strength | 5MG/5ML | ||||
| Approval Date: | Oct 17, 2011 | TE: | RLD: | No | |||||
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