Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076526
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOROURACIL | FLUOROURACIL | 2% | SOLUTION;TOPICAL | Prescription | AT | No | No |
FLUOROURACIL | FLUOROURACIL | 5% | SOLUTION;TOPICAL | Prescription | AT | No | 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 |
---|---|---|---|---|---|---|---|
11/05/2003 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2022 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
FLUOROURACIL
SOLUTION;TOPICAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFUDEX | FLUOROURACIL | 2% | SOLUTION;TOPICAL | Prescription | Yes | AT | 016831 | BAUSCH |
FLUOROURACIL | FLUOROURACIL | 2% | SOLUTION;TOPICAL | Prescription | No | AT | 076526 | TARO |
SOLUTION;TOPICAL; 5%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOROURACIL | FLUOROURACIL | 5% | SOLUTION;TOPICAL | Prescription | No | AT | 215612 | ENCUBE |
FLUOROURACIL | FLUOROURACIL | 5% | SOLUTION;TOPICAL | Prescription | No | AT | 076526 | TARO |