Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061769
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFADYL | CEPHAPIRIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFADYL | CEPHAPIRIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFADYL | CEPHAPIRIN SODIUM | EQ 4GM BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1974 | 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 |
|---|---|---|---|---|---|
| 06/11/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/21/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 07/17/1990 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |