Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020600
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAZORAC TAZAROTENE 0.05% GEL;TOPICAL Prescription None Yes Yes
TAZORAC TAZAROTENE 0.1% GEL;TOPICAL Prescription None 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
06/13/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020600_tazorac_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020600s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020600Orig1s010ltr.pdf
07/21/2017 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020600s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021184Orig1s009,020600Orig1s009ltr.pdf
02/25/2011 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020600s008ltr.pdf
12/02/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf
12/02/2003 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20600slr003,005ltr.pdf
06/17/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1999 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/16/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020600s010lbl.pdf
07/21/2017 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020600s009lbl.pdf
02/25/2011 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020600s008lbl.pdf
12/02/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf
12/02/2003 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20600slr003,005_tazorac_lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English