Details for New Drug Application (NDA): 091567
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NDA 091567 describes FEXOFENADINE HYDROCHLORIDE HIVES, which is a drug marketed by Dr Reddys Labs Ltd, Rising, Sciegen Pharms Inc, Sun Pharm Inds, Teva, and Wockhardt, and is included in six NDAs. It is available from fifty-three suppliers. Additional details are available on the FEXOFENADINE HYDROCHLORIDE HIVES profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
The generic ingredient in FEXOFENADINE HYDROCHLORIDE HIVES is fexofenadine hydrochloride. There are twenty-three drug master file entries for this compound. One hundred and three suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 091567
| Tradename: | FEXOFENADINE HYDROCHLORIDE HIVES |
| Applicant: | Sun Pharm Inds |
| Ingredient: | fexofenadine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091567
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 091567
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 091567 | ANDA | AMERISOURCE BERGEN | 46122-779 | 46122-779-58 | 3 BLISTER PACK in 1 CARTON (46122-779-58) / 5 TABLET, FILM COATED in 1 BLISTER PACK |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 091567 | ANDA | AMERISOURCE BERGEN | 46122-779 | 46122-779-61 | 1 BOTTLE in 1 CARTON (46122-779-61) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 6, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Feb 6, 2012 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Feb 6, 2012 | TE: | RLD: | No | |||||
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