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Application 020600
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TAZORAC | TAZAROTENE | GEL;TOPICAL | 0.05% | Yes | Yes |
| 002 | TAZORAC | TAZAROTENE | GEL;TOPICAL | 0.1% | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0023-0042 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 0023-0042 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 0023-0042 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 0023-8335 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 0023-8335 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 0023-8335 | TAZORAC | tazarotene | Allergan, Inc. | NDA | Current |
| 16110-042 | Tazorac | tazarotene | Almirall, LLC | NDA | Current |
| 16110-833 | Tazorac | tazarotene | Almirall, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53717 | SUPPL | 2018-04-17 |
| 53704 | SUPPL | 2018-04-17 |
| 49077 | SUPPL | 2017-07-25 |
| 49053 | SUPPL | 2017-07-25 |
| 12821 | SUPPL | 2011-03-04 |
| 2844 | SUPPL | 2011-03-02 |
| 34939 | SUPPL | 2003-12-08 |
| 34938 | SUPPL | 2003-12-08 |
| 25292 | SUPPL | 2003-12-08 |
| 2843 | SUPPL | 2003-12-08 |
| 41469 | ORIG | 2003-08-07 |