Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077856
Company: PRINSTON INC
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
06/28/2006 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-18 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/10/2016 SUPPL-11 Labeling-Medication Guide

Label is not available on this site.

06/20/2012 SUPPL-8 REMS-Modified

Label is not available on this site.

09/15/2011 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal, Labeling-Container/Carton Labels

Label is not available on this site.

10/21/2009 SUPPL-3 Labeling

Label is not available on this site.

07/09/2007 SUPPL-2 Labeling

Label is not available on this site.

05/01/2007 SUPPL-1 Labeling

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 075423 SUN PHARM INDS INC
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 075423 SUN PHARM INDS INC
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 075423 SUN PHARM INDS INC
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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