Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077856
Company: PRINSTON INC

Products on ANDA 077856

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077856

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-Medication Guide, Labeling-Package Insert		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-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 077856

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	AUROBINDO PHARMA USA
CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	077856	PRINSTON INC
CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	075468	RUBICON
CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	074979	SANDOZ
CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET;ORAL	Prescription	No	AB	074569	TEVA
KLONOPIN	CLONAZEPAM	0.5MG	TABLET;ORAL	Prescription	Yes	AB	017533	CHEPLAPHARM

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	AUROBINDO PHARMA USA
CLONAZEPAM	CLONAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	077856	PRINSTON INC
CLONAZEPAM	CLONAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	075468	RUBICON
CLONAZEPAM	CLONAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	074979	SANDOZ
CLONAZEPAM	CLONAZEPAM	1MG	TABLET;ORAL	Prescription	No	AB	074569	TEVA
KLONOPIN	CLONAZEPAM	1MG	TABLET;ORAL	Prescription	Yes	AB	017533	CHEPLAPHARM

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	AUROBINDO PHARMA USA
CLONAZEPAM	CLONAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	077856	PRINSTON INC
CLONAZEPAM	CLONAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	075468	RUBICON
CLONAZEPAM	CLONAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	074979	SANDOZ
CLONAZEPAM	CLONAZEPAM	2MG	TABLET;ORAL	Prescription	No	AB	074569	TEVA
KLONOPIN	CLONAZEPAM	2MG	TABLET;ORAL	Prescription	Yes	AB	017533	CHEPLAPHARM