Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075150
Company: AUROBINDO PHARMA USA

Products on ANDA 075150

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 075150

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/1998	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75150LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75150_Clonazepam.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2012	SUPPL-15	Labeling-Package Insert, REMS-Modified		Label is not available on this site.
04/08/2011	SUPPL-13	Labeling-Medication Guide, REMS-Proposal, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/15/2009	SUPPL-11	Labeling		Label is not available on this site.
11/24/2003	SUPPL-3	Labeling		Label is not available on this site.
02/28/2001	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075150

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