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Details for New Drug Application (NDA): 203330
» See Plans and Pricing
NDA 203330 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by P And L, Taro, Dr Reddys Labs Ltd, Mylan, Sun Pharm Inds, Teva, and Wockhardt Ltd, and is included in eight NDAs. It is available from fifty-nine 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. Ninety-seven 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. Ninety-seven 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: | P And L |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203330
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 203330 | ANDA | Walgreens | 0363-9230 | 0363-9230-04 | 1 BOTTLE, PLASTIC in 1 BOX (0363-9230-04) > 118 mL in 1 BOTTLE, PLASTIC |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 203330 | ANDA | EQUATE (Wal-Mart Stores, Inc.) | 49035-208 | 49035-208-04 | 1 BOTTLE, PLASTIC in 1 CARTON (49035-208-04) > 118 mL in 1 BOTTLE, PLASTIC |
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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