Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021184
Company: ALLERGAN
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 | AB | 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 | 208662 | COSETTE |
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; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAZAROTENE | TAZAROTENE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 208662 | COSETTE |
TAZAROTENE | TAZAROTENE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 217075 | PADAGIS ISRAEL |
TAZORAC | TAZAROTENE | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB | 021184 | ALLERGAN |
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 | 208662 | COSETTE |
TAZAROTENE | TAZAROTENE | 0.1% | CREAM;TOPICAL | Prescription | No | AB | 208258 | TARO |
TAZORAC | TAZAROTENE | 0.1% | CREAM;TOPICAL | Prescription | Yes | AB | 021184 | ALLERGAN |