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QUINAPRIL HYDROCHLORIDE

ANDA

QUINAPRIL HYDROCHLORIDE | A076607 | SUN PHARMACEUTICAL INDUSTRIES LTD

4 strengths0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs5 inactive

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

FARMHISPANIA SAQUINAPRIL HYDROCHLORIDE

DMF 167352003

LUPIN LTDQUINAPRIL HYDROCHLORIDE USP

DMF 179572004

APITORIA PHARMA PRIVATE LTDQUINAPRIL HYDROCHLORIDE USP

DMF 190462005

AARTI PHARMALABS LTDQUINAPRIL HYDROCHLORIDE USP

DMF 194132006

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDQUINAPRIL HYDROCHLORIDE USP

DMF 203152006

SIGNA SA DE CVInactiveQUINAPRIL HYDROCHLORIDE ACETONE SOLVATE

DMF 156192001

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveQUINAPRIL HYDROCHLORIDE USP

DMF 162612002

SOLARA ACTIVE PHARMA SCIENCES LTDInactiveQUINAPRIL HYDROCHLORIDE

DMF 203332007

MYLAN LABORATORIES LTDInactiveQUINAPRIL HYDROCHLORIDE USP

DMF 214762008

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveQUINAPRIL HYDROCHLORIDE USP

DMF 217512008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 30, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

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#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 15, 2004

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 15, 2004

#003 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 15, 2004

#004 — EQ 40MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 15, 2004