Drugs@FDA: FDA-Approved Drugs
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREVICON 21-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | TABLET;ORAL-21 | 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 |
|---|---|---|---|---|---|---|---|
| 12/26/1974 | 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 |
|---|---|---|---|---|---|
| 10/10/2017 | SUPPL-92 | Labeling-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-91 | 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-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-84 | Labeling |
Label is not available on this site. |
||
| 02/14/2000 | SUPPL-83 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-82 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-81 | Labeling |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-79 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1994 | SUPPL-77 | Labeling |
Label is not available on this site. |
||
| 09/19/1990 | SUPPL-76 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1989 | SUPPL-75 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-74 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1990 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 07/17/1986 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 11/13/1984 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1984 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 09/27/1984 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1984 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1983 | SUPPL-57 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1987 | SUPPL-56 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1982 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1978 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 07/05/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/05/1977 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/14/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1975 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/16/1976 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 10/10/2017 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf | |
| 08/09/2017 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf |