Details for New Drug Application (NDA): 208123
✉ Email this page to a colleague
NDA 208123 describes CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by P And L, Taro, Dr Reddys Labs Ltd, Rising, Sun Pharm Inds, Teva, and Wockhardt, and is included in eight NDAs. It is available from forty-one 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 one 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 one suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 208123
| Tradename: | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES |
| Applicant: | Taro |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208123
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 208123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 208123 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-2141 | 51672-2141-1 | 1 BOTTLE in 1 CARTON (51672-2141-1) / 240 mL in 1 BOTTLE |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | SUSPENSION;ORAL | 208123 | ANDA | Taro Pharmaceuticals U.S.A., Inc. | 51672-2141 | 51672-2141-8 | 1 BOTTLE in 1 CARTON (51672-2141-8) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Nov 9, 2017 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 30MG/5ML | ||||
| Approval Date: | Nov 9, 2017 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
