Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074869
Company: ACTAVIS ELIZABETH
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
10/31/1996 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
04/03/2013 SUPPL-29 Labeling-Package Insert, REMS

Label is not available on this site.

04/08/2011 SUPPL-27 Labeling, REMS-Proposal

Label is not available on this site.

10/15/2009 SUPPL-25 Labeling

Label is not available on this site.

10/05/2001 SUPPL-8 Labeling

Label is not available on this site.

11/02/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/25/2000 SUPPL-5 Labeling

Label is not available on this site.

03/12/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/24/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/10/1997 SUPPL-2 Labeling

Label is not available on this site.

05/23/1997 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 075150 MYLAN
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 075150 MYLAN
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 075150 MYLAN
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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