Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214136
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAZAROTENE | TAZAROTENE | 0.1% | GEL;TOPICAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/13/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214136Orig1s000ltr.pdf |
TAZAROTENE
GEL;TOPICAL; 0.1%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TAZAROTENE | TAZAROTENE | 0.1% | GEL;TOPICAL | Prescription | No | AB | 214136 | COSETTE |
TAZAROTENE | TAZAROTENE | 0.1% | GEL;TOPICAL | Prescription | No | AB | 213079 | PADAGIS ISRAEL |
TAZAROTENE | TAZAROTENE | 0.1% | GEL;TOPICAL | Prescription | No | AB | 213644 | SOLARIS PHARMA CORP |
TAZORAC | TAZAROTENE | 0.1% | GEL;TOPICAL | Prescription | Yes | AB | 020600 | ALLERGAN |