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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203039
Company: TEVA PHARMS USA

REMS

Products on ANDA 203039

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
CLOZAPINE	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203039

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2015	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203039Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/10/2021	SUPPL-12	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/29/2021	SUPPL-10	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/18/2021	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/16/2021	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/16/2019	SUPPL-5	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/16/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 203039

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/25/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203039Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 203039

CLOZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201824	MYLAN
CLOZAPINE	CLOZAPINE	150MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203039	TEVA PHARMS USA

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201824	MYLAN
CLOZAPINE	CLOZAPINE	200MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	203039	TEVA PHARMS USA

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