Drugs@FDA: FDA Approved Drug Products

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

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 PHARMS INC
ACITRETIN ACITRETIN 10MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 10MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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 PHARMS INC
ACITRETIN ACITRETIN 25MG CAPSULE;ORAL Prescription No AB 204633 SIGMAPHARM LABS LLC
SORIATANE ACITRETIN 25MG CAPSULE;ORAL Prescription Yes AB 019821 STIEFEL LABS INC

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