Viewing data from:

PERINDOPRIL ERBUMINE

ANDA

PERINDOPRIL ERBUMINE | A090072 | HIKMA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs3 inactive

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

ALIVUS LIFE SCIENCES LTDPERINDOPRIL ERBUMINE

DMF 177132004

PIRAMAL PHARMA LTDPERINDOPRIL ERBUMINE

DMF 281442014

MSN PHARMACHEM PRIVATE LTDPERINDOPRIL ERBUMINE USP

DMF 414972025

NORAMCO DELAWARE INCInactivePERINDOPRIL ERBUMINE

DMF 91651991

ORIL INDUSTRIEInactivePERINDOPRIL ERBUMINE

DMF 91711991

CIPLA LTDInactivePERINDOPRIL ERBUMINE MONOHYDRATE

DMF 201652007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 13, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 10, 2009

No patent or exclusivity listings for this strength.

#002 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 10, 2009

#003 — 8MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 10, 2009