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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090308
Company: BARR LABS INC

REMS

Products on ANDA 090308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLOZAPINE	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	No
CLOZAPINE	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	AB	No	Yes
CLOZAPINE	CLOZAPINE	12.5MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090308

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/09/2018	ORIG-2	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/090308Orig1s000ltr.pdf
11/25/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090308Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/10/2021	SUPPL-11	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/29/2021	SUPPL-9	REMS - MODIFIED - D-N-A		Label is not available on this site.
02/18/2021	SUPPL-8	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/16/2021	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/16/2019	SUPPL-3	REMS - MODIFIED - D-N-A		Label is not available on this site.
04/09/2021	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090308

CLOZAPINE

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090308	BARR LABS INC
CLOZAPINE	CLOZAPINE	25MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201824	MYLAN

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	090308	BARR LABS INC
CLOZAPINE	CLOZAPINE	100MG	TABLET, ORALLY DISINTEGRATING;ORAL	Prescription	No	AB	201824	MYLAN

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