Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208279
Company: GLENMARK PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 10MG 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
12/23/2016 ORIG-1 Approval STANDARD

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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