Drugs@FDA: FDA-Approved Drugs
Company: SERONO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FERTINEX | UROFOLLITROPIN | 150 IU/AMP | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| FERTINEX | UROFOLLITROPIN | 75 IU/AMP | INJECTABLE;SUBCUTANEOUS | Discontinued | None | No | No |
| METRODIN | UROFOLLITROPIN | 75 IU/AMP | INJECTABLE;INTRAMUSCULAR | Discontinued | None | No | No |
| METRODIN | UROFOLLITROPIN | 150 IU/AMP | INJECTABLE;INTRAMUSCULAR | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/1986 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD; Orphan |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/15/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/28/2000 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/24/1999 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/15/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1996 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1995 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/29/1995 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/28/1994 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/23/1996 | SUPPL-9 | Efficacy-New Route Of Administration |
Label is not available on this site. |
||
| 05/31/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1991 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1990 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/25/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/01/1988 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |