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BREVICON 21-DAY از شرکت ALLERGAN

تصویر پیدا نشد !

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 21-DAY از شرکت ALLERGAN

New Drug Application (NDA): 017566

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
حتما بخوانید : CEFIXIME از شرکت ALKEM LABS LTD
بخوانید  CELECOXIB از شرکت NANJING
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