Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016927
Company: GD SEARLE LLC
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMULEN 1/50-21 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.05MG;1MG | TABLET;ORAL-21 | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/1970 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/02/1999 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
| 04/20/1994 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 04/28/1993 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 12/16/1991 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-58 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/1991 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 03/13/1986 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 06/05/1985 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 02/12/1985 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/18/1984 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/03/1983 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1981 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |