Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017566
Company: ALLERGAN SALES LLC
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

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