Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061741
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROBAMPACIN | AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID | EQ 3.5GM BASE/BOT;1GM/BOT | FOR SUSPENSION;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
10/10/1973 | 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 |
---|---|---|---|---|---|
05/01/2024 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |