Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077147
Company: ACCORD HLTHCARE

Products on ANDA 077147

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 077147

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2005	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
07/24/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/24/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/24/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/19/2012	SUPPL-5	Labeling-Medication Guide		Label is not available on this site.
05/18/2015	SUPPL-4	Labeling-Container/Carton Labels		Label is not available on this site.
04/25/2011	SUPPL-1	Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077147

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