Viewing data from:

TERAZOSIN HYDROCHLORIDE

ANDA

TERAZOSIN HYDROCHLORIDE | A075498 | HIKMA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs11 inactive

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

CU CHEMIE UETIKON GMBHTERAZOSIN HYDROCHLORIDE ANHYDROUS

DMF 100351993

TAPI NL BVTERAZOSIN HYDROCHLORIDE

DMF 113001995

SIGNA SA DE CVTERAZOSIN HYDROCHLORIDE DIHYDRATE USP

DMF 182682005

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

DMF 201132006

JUBILANT PHARMOVA LTDTERAZOSIN HYDROCHLORIDE

DMF 210662007

BIOPHORE INDIA PHARMACEUTICALS PVT LTDTERAZOSIN HYDROCHLORIDE

DMF 375772022

SUMITOMO CHEMICAL CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 91571991

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveTERAZOSIN HYDROCHLORIDE

DMF 100541993

ORION CORP FERMIONInactiveTERAZOSIN HYDROCHLORIDE DIHYDRATE

DMF 118821996

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveTERAZOSIN HYDROCHLORIDE

DMF 122441996

CILAG AGInactiveTERAZOSIN HYDROCHLORIDE MONOHYDRATE

DMF 126491997

PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 145321999

CADILA HEALTHCARE LTDInactiveTERAZOSIN HYDROCHLORIDE ANHYDROUS

DMF 176052004

SECOND PHARMA CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 193622006

ARCHIMICA SRLInactiveTERAZOSIN HYDROCHLORIDE

DMF 194802006

STANDARD CHEM AND PHARM CO LTDInactiveTERAZOSIN HYDROCHLORIDE

DMF 200252006

CTX LIFE SCIENCES PVT LTDInactiveTERAZOSIN HYDROCHLORIDE DIHYDRATE USP

DMF 258292012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 12, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 1MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 12, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 2MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 12, 2001

#003 — EQ 5MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 12, 2001

#004 — EQ 10MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 12, 2001