Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MICRONOR | NORETHINDRONE | 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL-28 | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/02/1973 | 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 |
|---|---|---|---|---|---|
| 11/15/2021 | SUPPL-108 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016954s100s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016954Orig1s100, s108ltr.pdf | |
| 09/11/2014 | SUPPL-107 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2014 | SUPPL-106 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016954Orig1s106ltr.pdf | |
| 06/20/2008 | SUPPL-101 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/016954s101ltr.pdf | |
| 11/15/2021 | SUPPL-100 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016954s100s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/016954Orig1s100, s108ltr.pdf | |
| 10/01/2003 | SUPPL-92 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/16954slr092ltr.pdf |
| 06/20/2002 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-90 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/23/2000 | SUPPL-89 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/05/2000 | SUPPL-88 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-87 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1998 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 01/14/1997 | SUPPL-84 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1996 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-82 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/1995 | SUPPL-81 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-80 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1994 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 11/04/1993 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-77 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1990 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-73 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 10/28/1988 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/09/1988 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 11/23/1987 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1985 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 04/05/1985 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 06/21/1984 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1984 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 09/29/1983 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 06/15/1983 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/29/1982 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 11/20/1980 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1980 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1980 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1979 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/15/1979 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/19/1979 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/19/1978 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 06/21/1979 | SUPPL-39 | Unspecified |
Label is not available on this site. |
||
| 09/25/1978 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/17/1978 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1978 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/29/1978 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/18/1976 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1975 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1975 | SUPPL-6 | Unspecified |
Label is not available on this site. |
||
| 03/06/1975 | SUPPL-5 | Unspecified |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/15/2021 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016954s100s108lbl.pdf | |
| 11/15/2021 | SUPPL-100 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016954s100s108lbl.pdf | |
| 06/18/2014 | SUPPL-106 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016954s106lbl.pdf | |
| 06/20/2008 | SUPPL-101 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/016954s101lbl.pdf |