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DOXAZOSIN MESYLATE

ANDA

DOXAZOSIN MESYLATE | A208719 | ZYDUS PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CARDURA(TE code: AB)

API Supply Chain6 active DMFs8 inactive

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

EXCELLA GMBH AND CO KGDOXAZOSIN MESYLATE

DMF 126341997

DR REDDYS LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 127501997

APOTEX PHARMACHEM INDIA PVT LTDDOXAZOSIN MESYLATE USP

DMF 130391998

APITORIA PHARMA PRIVATE LTDDOXAZOSIN MESYLATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 199592006

COHANCE LIFESCIENCES LTDDOXAZOSIN MESYLATE USP

DMF 229412009

UNICHEM LABORATORIES LTDDOXAZOSIN MESYLATE USP

DMF 323752018

CIPLA LTDInactiveDOXAZOSIN MESYLATE

DMF 127841997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveDOXAZOSIN MESYLATE

DMF 138071998

CILAG AGInactiveDOXAZOSIN MESYLATE

DMF 141731999

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveDOXAZOSIN MESYLATE

DMF 142811999

MEDICHEM SAInactiveDOXAZOSIN MESYLATE

DMF 143661999

WOCKHARDT LTDInactiveDOXAZOSIN MESYLATE

DMF 152402001

CHONGQING BIOCARE PHARMACEUTICAL CO LTDInactiveDOXAZOSIN MESYLATE USP

DMF 206642007

STANDARD CHEM AND PHARM CO LTDInactiveDOXAZOSIN MESYLATE

DMF 207702007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 11, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 1MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 7, 2017

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2017

#003 — EQ 4MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2017

#004 — EQ 8MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 7, 2017