Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075468
Company: RUBICON

Products on ANDA 075468

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 075468

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75468ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/18/2016	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/10/2015	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/31/2013	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/06/2010	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/04/2003	SUPPL-4	Labeling		Label is not available on this site.
01/08/2002	SUPPL-3	Labeling		Label is not available on this site.
01/08/2002	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
01/08/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 075468

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