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Last Updated: March 28, 2024

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, Mylan, 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.
Summary for 203192
Tradename:ALFUZOSIN HYDROCHLORIDE
Applicant:Unichem
Ingredient:alfuzosin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203192
Mechanism of ActionAdrenergic 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jan 28, 2016TE:ABRLD:No

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