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BENAZEPRIL HYDROCHLORIDE

ANDA

BENAZEPRIL HYDROCHLORIDE | A076211 | TEVA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: LOTENSIN(TE code: AB)

API Supply Chain14 active DMFs4 inactive

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

W R GRACE AND CO -CONNBENAZEPRIL HYDROCHLORIDE

DMF 147202000

FARMHISPANIA SABENAZEPRIL HYDROCHLORIDE USP

DMF 154572001

SCINOPHARM TAIWAN LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 160722002

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 177922004

APITORIA PHARMA PRIVATE LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 190132005

AMINO CHEMICALS LTDBENAZEPRIL HYDROCHLORIDE

DMF 191482006

UNIMARK REMEDIES LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 194792006

LUPIN LTDBENAZEPRIL HYDROCHLORIDE USP (PROCESS B)

DMF 196972006

AARTI PHARMALABS LTDBENAZEPRIL HYDROCHLORIDE

DMF 200972006

AARTI PHARMALABS LTDBENAZEPRIL HYDROCHLORIDE POLYMORPH B

DMF 228462009

WISDOM PHARMACEUTICAL CO LTDBENAZEPRIL HYDROCHLORIDE

DMF 337442019

NURAY CHEMICALS PRIVATE LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 367682022

ZYDUS LIFESCIENCES LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 370492022

EMCURE PHARMACEUTICALS LTDBENAZEPRIL HYDROCHLORIDE USP

DMF 412782025

QUIMICA SINTETICA SAInactiveBENAZEPRIL HYDROCHLORIDE

DMF 156472001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveBENAZEPRIL HYDROCHLORIDE USP

DMF 157762001

LUPIN LTDInactiveBENAZEPRIL HYDROCHLORIDE

DMF 168572003

WISDOM PHARMACEUTICAL CO LTDInactiveBENAZEPRIL HYDROCHLORIDE

DMF 257382012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 12, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 11, 2004

No patent or exclusivity listings for this strength.

#002 — 10MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 11, 2004

#003 — 20MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 11, 2004

#004 — 40MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 11, 2004