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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074979
Company: SANDOZ

Products on ANDA 074979

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 074979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/1997	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74979ap.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2018	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
07/31/2017	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/18/2016	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/23/2012	SUPPL-15	REMS-Modified, Labeling-Medication Guide		Label is not available on this site.
03/30/2011	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels, REMS-Proposal		Label is not available on this site.
03/30/2011	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/23/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/18/2000	SUPPL-3	Labeling		Label is not available on this site.
02/02/2000	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 074979

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

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