Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208258
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAZAROTENE TAZAROTENE 0.1% CREAM;TOPICAL 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
04/03/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208258Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208258Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208258Orig1s000lbl.pdf

TAZAROTENE

CREAM;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AVAGE TAZAROTENE 0.1% CREAM;TOPICAL Prescription Yes AB 021184 ALLERGAN
TAZAROTENE TAZAROTENE 0.1% CREAM;TOPICAL Prescription No AB 208258 TARO
TAZORAC TAZAROTENE 0.1% CREAM;TOPICAL Prescription Yes AB 021184 ALLERGAN

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