Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORTHO-NOVUM 7/7/7-21 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-21 | Discontinued | None | No | No |
| ORTHO-NOVUM 7/7/7-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/04/1984 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017735Orig1s118,017919Orig1s100,018985Orig1s064ltr.pdf | |
| 10/29/2015 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017735Orig1s117,017919Orig1s099,018985Orig1s063ltr.pdf | |
| 09/11/2014 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2013 | SUPPL-60 | 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 |
| 10/02/2013 | SUPPL-56 | 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-54 | 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-53 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/017735s107,17919s089,018985s053,019653s048,19697s044,20301s027,21241s017ltr.pdf | |
| 10/03/2013 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050,019653Orig1s046,019697Orig1s042,020301Orig1s025ltr.pdf | |
| 06/03/2002 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/2002 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2001 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/06/2000 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/16/1995 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/03/1994 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1994 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/18/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/02/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/21/1984 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017735s118,017919s100,018985s064lbl.pdf | |
| 10/29/2015 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017735s117,017919s099,018985s063lbl.pdf | |
| 10/03/2013 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017735Orig1s104,017919Orig1s086,018985Orig1s050lbl.pdf | |
| 06/18/2012 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017735s107lbl.pdf |