Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-21 | Discontinued | None | Yes | No |
ORTHO-CEPT | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/14/1992 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020301s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020301Orig1s037ltr.pdf | |
12/01/2015 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020301Orig1s036ltr.pdf | |
10/02/2013 | SUPPL-34 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s114,017919Orig1s096,018985Orig1s060,019653Orig1s054,019697Orig1s050,020301Orig1s034ltr.pdf |
04/08/2014 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/02/2013 | SUPPL-30 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s110,017919Orig1s092,018985Orig1s056,019653Orig1s051,019697Orig1s047,020301Orig1s030ltr.pdf |
10/02/2013 | SUPPL-28 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s108,017919Orig1s090,018985Orig1s054,019653Orig1s049,019697Orig1s045,020301Orig1s028ltr.pdf |
06/18/2012 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf | |
10/03/2013 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf | |
02/21/2002 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/07/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
01/05/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/03/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/19/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/04/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
02/14/1996 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
03/04/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/21/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/04/1996 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/02/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/04/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/05/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/09/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020301s037lbl.pdf | |
12/01/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020301s036lbl.pdf | |
10/03/2013 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020301Orig1s025lbl.pdf | |
06/18/2012 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020301s027lbl.pdf |