Details for New Drug Application (NDA): 091567
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The generic ingredient in 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 091567
Tradename: | FEXOFENADINE HYDROCHLORIDE HIVES |
Applicant: | Sun Pharm Inds |
Ingredient: | fexofenadine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 | CVS PHARMACY, INC | 51316-800 | 51316-800-08 | 1 BOTTLE in 1 CARTON (51316-800-08) / 180 TABLET in 1 BOTTLE |
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 091567 | ANDA | CVS PHARMACY, INC | 51316-800 | 51316-800-15 | 1 BLISTER PACK in 1 CARTON (51316-800-15) / 15 TABLET in 1 BLISTER PACK |
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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