Details for New Drug Application (NDA): 076502
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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 four suppliers are listed for this compound. Additional details are available on the fexofenadine hydrochloride profile page.
Summary for 076502
Tradename: | FEXOFENADINE HYDROCHLORIDE HIVES |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | fexofenadine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076502
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 076502
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 076502 | ANDA | Walgreens Company | 0363-0783 | 0363-0783-24 | 4 BLISTER PACK in 1 CARTON (0363-0783-24) / 6 TABLET in 1 BLISTER PACK |
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | fexofenadine hydrochloride | TABLET;ORAL | 076502 | ANDA | Walgreens Company | 0363-0784 | 0363-0784-07 | 1 BLISTER PACK in 1 CARTON (0363-0784-07) / 5 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Apr 11, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Apr 11, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 180MG | ||||
Approval Date: | Apr 11, 2006 | TE: | AB | RLD: | No |
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