Details for New Drug Application (NDA): 203192
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NDA 203192 describes ALFUZOSIN HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Invagen Pharms, Norvium Bioscience, Sun Pharm, Torrent Pharms, Unichem, and Wockhardt, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the ALFUZOSIN HYDROCHLORIDE profile page.
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.
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 203192
| Tradename: | ALFUZOSIN HYDROCHLORIDE |
| Applicant: | Unichem |
| Ingredient: | alfuzosin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 203192
| Mechanism of Action | Adrenergic alpha-Antagonists |
Suppliers and Packaging for NDA: 203192
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203192 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-155 | 29300-155-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-01) |
| ALFUZOSIN HYDROCHLORIDE | alfuzosin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203192 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-155 | 29300-155-13 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 28, 2016 | TE: | AB | RLD: | No | ||||
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