Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018361
Company: EMD SERONO
Company: EMD SERONO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SEROPHENE | CLOMIPHENE CITRATE | 50MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 03/22/1982 | 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 |
|---|---|---|---|---|---|
| 07/31/2003 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/14/2001 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/01/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/30/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |