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ALFUZOSIN HYDROCHLORIDE

ANDA

ALFUZOSIN HYDROCHLORIDE | A203192 | UNICHEM LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: UROXATRAL(TE code: AB)

API Supply Chain9 active DMFs10 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDALFUZOSIN HYDROCHLORIDE USP

DMF 196752006

APITORIA PHARMA PRIVATE LTDALFUZOSIN HYDROCHLORIDE USP (NON-STERILE DRUG SUBSTANCE)

DMF 203072007

WOCKHARDT LTDALFUZOSIN HYDROCHLORIDE

DMF 204392007

HETERO DRUGS LTDALFUZOSIN HYDROCHLORIDE

DMF 205772007

APOTEX INCALFUZOSIN HYDROCHLORIDE USP

DMF 205952007

MSN LABORATORIES PRIVATE LTDALFUZOSIN HYDROCHLORIDE USP [ROUTE CODE-"AE"]

DMF 208672007

SANOFI CHIMIEALFUZOSIN HYDROCHLORIDE

DMF 208882007

UNICHEM LABORATORIES LTDALFUZOSIN HYDROCHLORIDE USP

DMF 226382009

TORRENT PHARMACEUTICALS LTDALFUZOSIN HYDROCHLORIDE USP

DMF 236032010

SANOFI SYNTHELABO INCInactiveALFUZOSIN HYDROCHLORIDE DRUG SUBSTANCE

DMF 119761996

FINORGAInactiveALFUZOSIN HYDROCHLORIDE

DMF 125461997

EXCELLA GMBH AND CO KGInactiveALFUZOSIN HYDROCHLORIDE

DMF 176242004

CIPLA LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 191802006

FARMAK ASInactiveALFUZOSIN HYDROCHLORIDE

DMF 194762006

STANDARD CHEM AND PHARM CO LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 197862006

DR REDDYS LABORATORIES LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 199612006

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 203502007

CADILA HEALTHCARE LTDInactiveALFUZOSIN HYDROCHLORIDE

DMF 203792007

LUNDBECK PHARMACEUTICALS ITALY SPAInactiveALFUZOSIN HYDROCHLORIDE

DMF 205402007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 29, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Jan 28, 2016

No patent or exclusivity listings for this strength.