Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017743
Company: ALLERGAN SALES LLC
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 Prescription AB 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
08/09/2017 SUPPL-88 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-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
08/09/2017 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf

BREVICON 28-DAY

TABLET;ORAL-28; 0.035MG;0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREVICON 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 017743 ALLERGAN SALES LLC
CYCLAFEM 0.5/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 203413 VINTAGE PHARMS
CYONANZ ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 207055 AUROBINDO PHARMA LTD
MODICON 28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription Yes AB 017735 JANSSEN PHARMS
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 070686 MAYNE PHARMA
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 200488 MYLAN LABS LTD
NORTREL 0.5/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 072695 BARR
WERA ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;0.5MG TABLET;ORAL-28 Prescription No AB 091204 NOVAST LABS LTD

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