اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BREVICON 28-DAY از شرکت ALLERGAN
New Drug Application (NDA): 017743
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BREVICON 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/29/1976 | 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 |
|---|---|---|---|---|---|
| 10/10/2017 | SUPPL-89 | Labeling-Package Insert |
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-88 | Labeling-Package Insert |
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-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 02/14/2000 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1999 | SUPPL-72 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1997 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-70 | Labeling |
Label is not available on this site. |
||
| 08/30/1995 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 07/31/1992 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1994 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 09/19/1990 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1989 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1990 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 07/17/1986 | SUPPL-61 | Labeling |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 11/13/1984 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1984 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 09/27/1984 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/1984 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/19/1983 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/06/1984 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 07/26/1983 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1983 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1987 | SUPPL-45 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/16/1984 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1982 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1982 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1980 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1980 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1979 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1978 | SUPPL-22 | 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. |
||
| 05/26/1978 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/14/1977 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/01/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/14/1980 | SUPPL-3 | 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-89 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf | |
| 08/09/2017 | SUPPL-88 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf |
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