Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211644
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
01/25/2019 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
TRETINOIN
CREAM;TOPICAL; 0.05%
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
RETIN-A | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB1 | 017522 | VALEANT BERMUDA |
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075265 | PADAGIS US |
TRETINOIN | TRETINOIN | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211644 | TARO |