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TRANDOLAPRIL

ANDA

TRANDOLAPRIL | A077489 | TEVA PHARMACEUTICALS USA

3 strengths0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs7 inactive

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

LUPIN LTDTRANDOLAPRIL USP

DMF 176582004

ALIVUS LIFE SCIENCES LTDTRANDOLAPRIL USP

DMF 181652005

APITORIA PHARMA PRIVATE LTDTRANDOLAPRIL USP

DMF 195482006

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveTRANDOLAPRIL USP

DMF 175732004

HETERO DRUGS LTDInactiveTRANDOLAPRIL

DMF 176222004

DR REDDYS LABORATORIES LTDInactiveTRANDOLAPRIL

DMF 184672005

ROLABO OUTSOURCING SLInactiveTRANDOLAPRIL

DMF 189472005

WOCKHARDT LTDInactiveTRANDOLAPRIL

DMF 197202006

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveTRANDOLAPRIL EP

DMF 206812007

BACHEM SAInactiveTRANDOLAPRIL

DMF 248552011

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 28, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 12, 2006

No patent or exclusivity listings for this strength.

#002 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 12, 2006

#003 — 4MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 12, 2006