Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077684
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/21/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077684s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/24/2009 SUPPL-3 Labeling

Label is not available on this site.

TRETINOIN

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription No AB 201687 ANCHEN PHARMS
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription No AB 077684 BARR LABS INC
TRETINOIN TRETINOIN 10MG CAPSULE;ORAL Prescription No AB 208279 GLENMARK PHARMS LTD

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