Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062885
Company: APOTHECON
Company: APOTHECON
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIMOX | AMOXICILLIN | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
TRIMOX | AMOXICILLIN | 250MG/5ML | 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 |
---|---|---|---|---|---|---|---|
03/08/1988 | 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 |
---|---|---|---|---|---|
02/18/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |