Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061763
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VELOSEF '125' | CEPHRADINE | 125MG/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| VELOSEF '250' | CEPHRADINE | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/1974 | 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 |
|---|---|---|---|---|---|
| 03/24/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |