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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091455
Company: BARR LABS INC

Products on ANDA 091455

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	AB	No	No
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091455

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/091455Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2018	SUPPL-12	Labeling-Patient Package Insert		Label is not available on this site.
04/19/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
07/20/2015	SUPPL-2	Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 091455

ACITRETIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	091455	BARR LABS INC
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	202148	MYLAN
ACITRETIN	ACITRETIN	10MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091455	BARR LABS INC
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	202552	IMPAX LABS INC
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	202148	MYLAN
ACITRETIN	ACITRETIN	25MG	CAPSULE;ORAL	Prescription	No	AB	204633	SIGMAPHARM LABS LLC

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