Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211644
Company: TARO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription AB1 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
01/25/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TRETINOIN

CREAM;TOPICAL; 0.05%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RETIN-A TRETINOIN 0.05% CREAM;TOPICAL Prescription Yes AB1 017522 VALEANT BERMUDA
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB1 075265 PERRIGO PHARMA INTL
TRETINOIN TRETINOIN 0.05% CREAM;TOPICAL Prescription No AB1 211644 TARO PHARMS

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