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LORAZEPAM

ANDA

LORAZEPAM | A076045 | SUN PHARMACEUTICAL INDUSTRIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: ATIVAN(TE code: AB)

API Supply Chain8 active DMFs4 inactive

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

CAMBREX PROFARMACO MILANO SRLLORAZEPAM

DMF 45171982

FIS FABBRICA ITALIANA SINTETICI SPALORAZEPAM

DMF 50271983

EVONIK OPERATIONS GMBHLORAZEPAM

DMF 50411983

RL FINE CHEM PVT LTDLORAZEPAM

DMF 190062005

CENTAUR PHARMACEUTICALS PVT LTDLORAZEPAM USP

DMF 224602009

MALLADI DRUGS AND PHARMACEUTICALS LTDLORAZEPAM

DMF 232472009

KALINTIS HEALTHCARE PVT LTDLORAZEPAM USP

DMF 352992020

STHREE CHEMICALS PRIVATE LIMITEDLORAZEPAM USP

DMF 407542024

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveLORAZEPAM

DMF 57471985

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLORAZEPAM USP

DMF 151562000

CIPLA LTDInactiveLORAZEPAM USP

DMF 177652004

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLORAZEPAM

DMF 192682006

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 15, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 29, 2001

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 29, 2001

#003 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 29, 2001