Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060593
Company: CEROVENE INC
Company: CEROVENE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEROMYCIN | CYCLOSERINE | 250MG | CAPSULE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/29/1964 | 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 |
|---|---|---|---|---|---|
| 03/03/2023 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2018 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2018 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2018 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2018 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-28 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/10/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/21/2001 | SUPPL-26 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/04/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1993 | SUPPL-20 | Bioequivalence |
Label is not available on this site. |
||
| 09/19/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/16/1992 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |