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CLONAZEPAM

ANDA

CLONAZEPAM | A074920 | TEVA PHARMACEUTICALS USA INC

3 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs3 inactive

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

FIS FABBRICA ITALIANA SINTETICI SPACLONAZEPAM

DMF 75051988

CAMBREX PROFARMACO MILANO SRLCLONAZEPAM

DMF 113511995

PH HEALTH LTDCLONAZEPAM

DMF 162452002

SUN PHARMACEUTICAL INDUSTRIES LTDCLONAZEPAM USP

DMF 177272004

APOTEX PHARMACHEM INDIA PVT LTDCLONAZEPAM USP

DMF 221672008

CENTAUR PHARMACEUTICALS PVT LTDCLONAZEPAM USP

DMF 225802009

R L FINE CHEM PVT LTDCLONAZEPAM

DMF 380702023

DIOSYNTH BVInactiveCLONAZEPAM

DMF 86781990

HOECHST CELANESE CORPInactiveCLONAZEPAM

DMF 118971996

LAKE CHEMICALS PRIVATE LTDInactiveCLONAZEPAM

DMF 225832009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 4, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 4, 1998

No patent or exclusivity listings for this strength.

#002 — 1MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 4, 1998

#003 — 2MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 4, 1998