Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018168
Company: GD SEARLE LLC
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEMULEN 1/35-21 | ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE | 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/30/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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-26 | Labeling |
Label is not available on this site. |
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| 04/20/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 04/28/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/16/1991 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/28/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/14/1991 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 10/23/1986 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 06/10/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 03/13/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 06/05/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/18/1985 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/05/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/12/1985 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/06/1984 | SUPPL-4 | Labeling |
Label is not available on this site. |