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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, Athem, Aurobindo Pharma, Cypress Pharm, Lannett Co Inc, Perrigo R And D, Pharm Assoc, Ranbaxy Labs Ltd, Taro, Torrent, Tris Pharma Inc, Jubilant Generics, and Sun Pharm, and is included in fifteen NDAs. It is available from twenty-nine 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 thirty-three 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 thirty-three 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: | Athem |
| Ingredient: | cetirizine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 091327
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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