Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214845
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOROURACIL | FLUOROURACIL | 5% | CREAM;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 |
---|---|---|---|---|---|---|---|
10/07/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/22/2022 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
FLUOROURACIL
CREAM;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
EFUDEX | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | Yes | AB | 016831 | BAUSCH |
FLUOROURACIL | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | No | AB | 214845 | ACCORD HLTHCARE |
FLUOROURACIL | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | No | AB | 077524 | DR REDDYS LABS SA |
FLUOROURACIL | FLUOROURACIL | 5% | CREAM;TOPICAL | Prescription | No | AB | 090368 | TARO |