Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NORINYL 1+35 21-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-21 | Discontinued | None | No | No |
NORINYL 1+35 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | 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 |
---|---|---|---|---|---|---|---|
12/27/1974 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-86 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017565s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/017565Orig1s086ltr.pdf | |
10/10/2017 | SUPPL-85 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s085,017566Orig1s092,017743Orig1s089ltr.pdf | |
08/09/2017 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017565Orig1s084,017566Orig1s091,017743Orig1s088ltr.pdf | |
08/15/2001 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/24/2000 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
02/04/1999 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/16/1998 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/1997 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/13/1994 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
12/13/1994 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
08/30/1995 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
07/31/1992 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/04/1994 | SUPPL-62 | Labeling |
Label is not available on this site. |
||
09/19/1990 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/24/1989 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/22/1989 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/02/1990 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
07/17/1986 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
10/25/1985 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
04/16/1985 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
11/13/1984 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/1984 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
06/12/1984 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
09/27/1984 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/07/1984 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
07/26/1983 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/06/1984 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
06/13/1983 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/22/1986 | SUPPL-42 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
05/16/1984 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/29/1982 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/11/1982 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/1980 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/18/1980 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/31/1980 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/26/1980 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
07/18/1979 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/18/1979 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/06/1978 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/06/1978 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/26/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/01/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
07/01/1977 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
10/14/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
05/16/1975 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/16/1975 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/16/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/16/1975 | 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 |
---|---|---|---|---|---|
04/29/2022 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017565s086lbl.pdf | |
04/29/2022 | SUPPL-86 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/017565s086lbl.pdf | |
10/10/2017 | SUPPL-85 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf | |
08/09/2017 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf |