Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017565
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORINYL 1+35 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-21 Prescription AB No No
NORINYL 1+35 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG 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
12/27/1974 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-85 Labeling-Patient 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-84 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-71 Manufacturing (CMC)

Label is not available on this site.

01/24/2000 SUPPL-70 Labeling

Label is not available on this site.

02/04/1999 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1998 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

07/30/1997 SUPPL-67 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-66 Labeling

Label is not available on this site.

12/13/1994 SUPPL-65 Labeling

Label is not available on this site.

08/30/1995 SUPPL-64 Labeling

Label is not available on this site.

07/31/1992 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-62 Labeling

Label is not available on this site.

09/19/1990 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/1989 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1989 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1990 SUPPL-58 Labeling

Label is not available on this site.

07/17/1986 SUPPL-55 Labeling

Label is not available on this site.

10/25/1985 SUPPL-54 Labeling

Label is not available on this site.

04/16/1985 SUPPL-53 Labeling

Label is not available on this site.

11/13/1984 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

07/30/1984 SUPPL-50 Labeling

Label is not available on this site.

06/12/1984 SUPPL-49 Labeling

Label is not available on this site.

09/27/1984 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/1984 SUPPL-46 Labeling

Label is not available on this site.

07/26/1983 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/06/1984 SUPPL-44 Labeling

Label is not available on this site.

06/13/1983 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1986 SUPPL-42 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/16/1984 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1982 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1982 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1980 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/1980 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1980 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/26/1980 SUPPL-28 Labeling

Label is not available on this site.

07/18/1979 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/18/1979 SUPPL-23 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.

11/06/1978 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1978 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1977 SUPPL-10 Labeling

Label is not available on this site.

07/01/1977 SUPPL-9 Labeling

Label is not available on this site.

10/14/1980 SUPPL-8 Labeling

Label is not available on this site.

05/16/1975 SUPPL-6 Labeling

Label is not available on this site.

05/16/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1976 SUPPL-3 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-85 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s085,017566s092,017743s089lbl.pdf
08/09/2017 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017565s084,017566s091,017743s088lbl.pdf

NORINYL 1+35 21-DAY

TABLET;ORAL-21; 0.035MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NORINYL 1+35 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-21 Prescription No AB 017565 ALLERGAN
NORTREL 1/35-21 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-21 Prescription No AB 072693 BARR

NORINYL 1+35 28-DAY

TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALYACEN 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 091634 GLENMARK GENERICS
CYCLAFEM 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 076337 VINTAGE PHARMS LLC
DASETTA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 090948 NOVAST LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 206864 ACCORD HLTHCARE
NORETHINDRONE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 070687 WATSON LABS TEVA
NORINYL 1+35 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 017565 ALLERGAN
NORTREL 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 072696 BARR
NYLIA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 207056 AUROBINDO PHARMA LTD
PIRMELLA 1/35 ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG;1MG TABLET;ORAL-28 Prescription No AB 201512 LUPIN LTD

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