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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206433
Company: AUROBINDO PHARMA

REMS

Products on ANDA 206433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	AB	No	No
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	AB	No	No
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	AB	No	No
CLOZAPINE	CLOZAPINE	200MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206433Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
08/14/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/10/2021	SUPPL-13	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/29/2021	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/14/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/18/2021	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
08/14/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/16/2019	SUPPL-4	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/25/2017	SUPPL-2	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
04/25/2017	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206433

CLOZAPINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	No	AB	202873	ACCORD HLTHCARE
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	No	AB	206433	AUROBINDO PHARMA
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	No	AB	074949	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	No	AB	075417	MYLAN
CLOZAPINE	CLOZAPINE	25MG	TABLET;ORAL	Prescription	No	AB	075713	SUN PHARM INDS INC
CLOZARIL	CLOZAPINE	25MG	TABLET;ORAL	Prescription	Yes	AB	019758	HERITAGE LIFE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	No	AB	206433	AUROBINDO PHARMA
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	No	AB	074949	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	No	AB	076809	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	No	AB	075417	MYLAN
CLOZAPINE	CLOZAPINE	50MG	TABLET;ORAL	Prescription	No	AB	075713	SUN PHARM INDS INC
CLOZARIL	CLOZAPINE	50MG	TABLET;ORAL	Prescription	Yes	AB	019758	HERITAGE LIFE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	202873	ACCORD HLTHCARE
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	206433	AUROBINDO PHARMA
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	074949	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	076809	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	075417	MYLAN
CLOZAPINE	CLOZAPINE	100MG	TABLET;ORAL	Prescription	No	AB	075713	SUN PHARM INDS INC
CLOZARIL	CLOZAPINE	100MG	TABLET;ORAL	Prescription	Yes	AB	019758	HERITAGE LIFE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOZAPINE	CLOZAPINE	200MG	TABLET;ORAL	Prescription	No	AB	206433	AUROBINDO PHARMA
CLOZAPINE	CLOZAPINE	200MG	TABLET;ORAL	Prescription	No	AB	076809	IVAX SUB TEVA PHARMS
CLOZAPINE	CLOZAPINE	200MG	TABLET;ORAL	Prescription	No	AB	075417	MYLAN
CLOZAPINE	CLOZAPINE	200MG	TABLET;ORAL	Prescription	No	AB	075713	SUN PHARM INDS INC
CLOZARIL	CLOZAPINE	200MG	TABLET;ORAL	Prescription	Yes	AB	019758	HERITAGE LIFE

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