Drugs@FDA: FDA-Approved Drugs
Company: ORGANON USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOGEN | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-21 | Discontinued | None | No | No |
DESOGEN | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG | TABLET;ORAL-28 | 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 |
---|---|---|---|---|---|---|---|
12/10/1992 | ORIG-1 | Approval | Type 1 - New Molecular Entity and 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 |
---|---|---|---|---|---|
08/09/2017 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020071Orig1s025ltr.pdf | |
06/15/2018 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020071s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020071Orig1s023ltr.pdf | |
11/30/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/12/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/11/2016 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/2007 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020071s017ltr.pdf | |
03/08/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/11/2004 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20071s014ltr.pdf |
11/27/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/24/1998 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
11/20/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/20/1997 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/05/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
07/26/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
04/25/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/18/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/03/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
04/28/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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03/09/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/15/2018 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020071s023lbl.pdf | |
08/09/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020071s025lbl.pdf | |
06/07/2007 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020071s017lbl.pdf |