Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074964
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription AB No No
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/30/1997 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/05/2015 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

10/15/2009 SUPPL-15 Labeling

Label is not available on this site.

10/20/2004 SUPPL-7 Labeling

Label is not available on this site.

10/28/2003 SUPPL-5 Labeling

Label is not available on this site.

12/22/2000 SUPPL-4 Labeling

Label is not available on this site.

04/12/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

03/21/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/21/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLONAZEPAM

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 0.5MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 0.5MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 1MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 1MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 077147 ACCORD HLTHCARE
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074869 ACTAVIS ELIZABETH
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 077856 PRINSTON INC
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074979 SANDOZ
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074569 TEVA
CLONAZEPAM CLONAZEPAM 2MG TABLET;ORAL Prescription No AB 074964 WATSON LABS
KLONOPIN CLONAZEPAM 2MG TABLET;ORAL Prescription Yes AB 017533 ROCHE

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