Details for New Drug Application (NDA): 079060
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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 079060
Tradename: | ALFUZOSIN HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | alfuzosin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 079060
Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 079060
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079060 | ANDA | Northwind Pharmaceuticals, LLC | 51655-087 | 51655-087-52 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51655-087-52) |
ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079060 | ANDA | Rising Pharma Holdings, Inc. | 57237-114 | 57237-114-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 30, 2012 | TE: | AB | RLD: | No |
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