Tri-Norinyl 21-Day, Tri-Norinyl 28-Day

NDA 18977, held by Dr Reddys Labs SA. Ethinyl Estradiol; Norethindrone.

As of Nov 14, 2026, NDA 18977 (Tri-Norinyl 21-Day, Tri-Norinyl 28-Day), held by Dr Reddys Labs SA, was first approved by FDA on Apr 11, 1984, with 28 approved supplements and 0 published complete response letters.

First approved: Apr 11, 1984
Review: Standard
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Apr 11, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Tri-Norinyl 21-Day0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG · tablet;oral-21	Ethinyl Estradiol; Norethindrone	Discontinued
Tri-Norinyl 28-Day0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG · tablet;oral-28	Ethinyl Estradiol; Norethindrone	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 43Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 41Labeling · Standard review	Approved	Letter Label
Aug 15, 2001	Supplement 28Manufacturing · Standard review	Approved	None posted
Feb 14, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 24, 2000	Supplement 27Labeling · Standard review	Approved	None posted
May 14, 1999	Supplement 24Labeling · Standard review	Approved	None posted
Feb 4, 1999	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 30, 1997	Supplement 23Manufacturing · Standard review	Approved	None posted
Feb 22, 1996	Supplement 22Labeling · Standard review	Approved	None posted
Aug 30, 1995	Supplement 19Labeling · Standard review	Approved	None posted
Dec 13, 1994	Supplement 21Labeling · Standard review	Approved	None posted
Dec 13, 1994	Supplement 20Labeling · Standard review	Approved	None posted
Feb 4, 1994	Supplement 17Labeling	Approved	None posted
Jul 31, 1992	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 27, 1990	Supplement 16Labeling	Approved	None posted
Sep 19, 1990	Supplement 15Manufacturing · Standard review	Approved	None posted
Oct 23, 1989	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 23, 1989	Supplement 13Manufacturing · Standard review	Approved	None posted
Feb 22, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 22, 1989	Supplement 10Labeling	Approved	None posted
Feb 3, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Oct 17, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 17, 1986	Supplement 8Labeling	Approved	None posted
Oct 25, 1985	Supplement 7Labeling	Approved	None posted
Apr 16, 1985	Supplement 6Labeling	Approved	None posted
Dec 5, 1984	Supplement 1Labeling	Approved	None posted
Nov 13, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 27, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 11, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18977
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters