Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074569
Company: TEVA
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
09/10/1996 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
07/18/2016 SUPPL-41 Labeling-Package Insert

Label is not available on this site.

07/19/2012 SUPPL-40 REMS-Proposal

Label is not available on this site.

04/08/2011 SUPPL-38 REMS-Proposal

Label is not available on this site.

04/08/2011 SUPPL-37 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/15/2009 SUPPL-33 Labeling

Label is not available on this site.

10/15/2009 SUPPL-32 Labeling

Label is not available on this site.

05/07/2009 SUPPL-31 Labeling

Label is not available on this site.

10/16/2001 SUPPL-19 Labeling

Label is not available on this site.

10/13/2000 SUPPL-18 Labeling

Label is not available on this site.

12/02/1999 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

12/02/1999 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

02/12/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/12/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/22/1998 SUPPL-7 Labeling

Label is not available on this site.

06/22/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/22/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-4 Labeling

Label is not available on this site.

11/25/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/28/1998 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 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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