Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018977
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRI-NORINYL 21-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-21 Discontinued None No No
TRI-NORINYL 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-28 Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/11/1984 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-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018977s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018977Orig1s041ltr.pdf
08/15/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

01/24/2000 SUPPL-27 Labeling

Label is not available on this site.

02/14/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/04/1999 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1999 SUPPL-24 Labeling

Label is not available on this site.

07/30/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/22/1996 SUPPL-22 Labeling

Label is not available on this site.

12/13/1994 SUPPL-21 Labeling

Label is not available on this site.

12/13/1994 SUPPL-20 Labeling

Label is not available on this site.

08/30/1995 SUPPL-19 Labeling

Label is not available on this site.

07/31/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/04/1994 SUPPL-17 Labeling

Label is not available on this site.

09/27/1990 SUPPL-16 Labeling

Label is not available on this site.

09/19/1990 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/23/1989 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1989 SUPPL-12 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/22/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/22/1989 SUPPL-10 Labeling

Label is not available on this site.

07/17/1986 SUPPL-8 Labeling

Label is not available on this site.

10/25/1985 SUPPL-7 Labeling

Label is not available on this site.

04/16/1985 SUPPL-6 Labeling

Label is not available on this site.

11/13/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/17/1986 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

09/27/1984 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/05/1984 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
08/09/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018977s041lbl.pdf

TRI-NORINYL 21-DAY

There are no Therapeutic Equivalents.

TRI-NORINYL 28-DAY

TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARANELLE ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-28 Prescription No AB 076783 BARR
TRI-NORINYL 28-DAY ETHINYL ESTRADIOL; NORETHINDRONE 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG TABLET;ORAL-28 Prescription Yes AB 018977 MAYNE PHARMA

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