Details for New Drug Application (NDA): 090284
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The generic ingredient in ALFUZOSIN HYDROCHLORIDE is alfuzosin hydrochloride. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the alfuzosin hydrochloride profile page.
Summary for 090284
Tradename: | ALFUZOSIN HYDROCHLORIDE |
Applicant: | Invagen Pharms |
Ingredient: | alfuzosin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090284
Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 090284
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090284 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | 43353-945-16 | 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-16) |
ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 090284 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | 43353-945-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-945-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 17, 2012 | TE: | AB | RLD: | No |
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