Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CREAM;TOPICAL | 0.05% | 1 | TAZORAC | TAZAROTENE |
| 002 | CREAM;TOPICAL | 0.1% | 1 | TAZORAC | TAZAROTENE |
| 003 | CREAM;TOPICAL | 0.1% | 1 | AVAGE | TAZAROTENE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-09-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2002-09-30 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-12-13 | STANDARD Tazorac label updated |
| LABELING; Labeling | SUPPL | 8 | AP | 2016-09-16 | STANDARD Avage label updated |
| LABELING; Labeling | SUPPL | 9 | AP | 2017-07-21 | STANDARD Label for Avage and Tazorac |
Submissions Property Types
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 31 |
TE Codes
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
ALLERGAN
cder:Array
(
[0] => Array
(
[ApplNo] => 21184
[companyName] => ALLERGAN
[docInserts] => ["",""]
[products] => [{"drugName":"AVAGE","activeIngredients":"TAZAROTENE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TAZORAC","activeIngredients":"TAZAROTENE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TAZORAC","activeIngredients":"TAZAROTENE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/21\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021184s009lbl.pdf\"}]","notes":"Label for Avage and Tazorac"},{"actionDate":"09\/16\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021184s008lbl.pdf\"}]","notes":"Avage label updated"},{"actionDate":"12\/13\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021184s007lbl.pdf\"}]","notes":"Tazorac label updated"},{"actionDate":"09\/30\/2002","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21184s2lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2001","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21184s1lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/21184lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AVAGE","submission":"TAZAROTENE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAZORAC","submission":"TAZAROTENE","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAZORAC","submission":"TAZAROTENE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2017-07-21
)
)