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Details for New Drug Application (NDA): 203330
NDA 203330 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Actavis Mid Atlantic, Taro Pharm, Dr Reddys Labs Ltd, Mylan, Sun Pharm Inds, Teva, and Wockhardt Ltd, and is included in eight NDAs. It is available from eighty-two suppliers. Additional details are available on the CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES profile page.
The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and thirteen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
The generic ingredient in CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and thirteen suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 203330
| Tradename: | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES |
| Applicant: | Actavis Mid Atlantic |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Nov 18, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Nov 18, 2014 | TE: | RLD: | No | |||||
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