Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021184
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVAGE TAZAROTENE 0.1% CREAM;TOPICAL Prescription AB Yes Yes
TAZORAC TAZAROTENE 0.05% CREAM;TOPICAL Prescription None Yes Yes
TAZORAC TAZAROTENE 0.1% CREAM;TOPICAL Prescription AB Yes 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
09/29/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21184ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-184_Tazorac.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
Label for Avage and Tazorac https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf
09/16/2016 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
Avage label updated https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021184Orig1s008ltr.pdf
12/13/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
Tazorac label updated https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021184Orig1s007ltr.pdf
09/30/2002 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21184se1-002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-184s002_Avage.cfm
10/11/2001 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21184s1ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-184S001_Tazorac.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2017 SUPPL-9 Labeling-Package Insert Label (PDF) Label for Avage and Tazorac https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021184s009lbl.pdf
09/16/2016 SUPPL-8 Labeling-Package Insert Label (PDF) Avage label updated https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021184s008lbl.pdf
12/13/2013 SUPPL-7 Labeling-Package Insert Label (PDF) Tazorac label updated https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021184s007lbl.pdf
09/30/2002 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21184s2lbl.pdf
10/11/2001 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21184s1lbl.pdf
09/29/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21184lbl.pdf

AVAGE

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

TAZORAC

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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