Triphasil-21

NDA 19192, held by Wyeth Pharms. Ethinyl Estradiol; Levonorgestrel.

As of Nov 14, 2026, NDA 19192 (Triphasil-21), held by Wyeth Pharms, was first approved by FDA on Nov 1, 1984, with 37 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1984
Review: Standard
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Nov 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Triphasil-210.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Levonorgestrel	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 49Labeling · Standard review	Approved	Letter Label
May 8, 2019	Supplement 48Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 47Labeling · Standard review	Approved	Letter Label
Mar 6, 2002	Supplement 37Manufacturing · Standard review	Approved	None posted
Mar 23, 2000	Supplement 35Labeling · Standard review	Approved	None posted
Feb 2, 2000	Supplement 33Labeling · Standard review	Approved	None posted
Dec 11, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Mar 11, 1998	Supplement 32Manufacturing · Standard review	Approved	None posted
May 17, 1996	Supplement 31Manufacturing · Standard review	Approved	None posted
Oct 11, 1995	Supplement 30Manufacturing · Standard review	Approved	None posted
May 3, 1995	Supplement 29Labeling · Standard review	Approved	None posted
May 3, 1995	Supplement 28Labeling · Standard review	Approved	None posted
May 27, 1994	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 20, 1994	Supplement 25Labeling · Standard review	Approved	None posted
Apr 8, 1994	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 29, 1993	Supplement 23Labeling	Approved	None posted
Mar 9, 1993	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 10, 1992	Supplement 22Manufacturing · Standard review	Approved	None posted
Oct 7, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 15, 1991	Supplement 14Manufacturing · Standard review	Approved	None posted
May 20, 1991	Supplement 21Manufacturing · Standard review	Approved	None posted
May 3, 1991	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 8, 1990	Supplement 12Labeling	Approved	None posted
May 30, 1990	Supplement 19Labeling	Approved	None posted
May 15, 1990	Supplement 18Manufacturing · Standard review	Approved	None posted
Jan 18, 1990	Supplement 17Manufacturing · Standard review	Approved	None posted
May 19, 1989	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 28, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Apr 27, 1988	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 27, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
May 15, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 25, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 15, 1986	Supplement 5Labeling	Approved	None posted
May 28, 1986	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 20, 1985	Supplement 3Labeling	Approved	None posted
Sep 6, 1985	Supplement 2Labeling	Approved	None posted
Jul 29, 1985	Supplement 1Manufacturing · Standard review	Approved	None posted
Nov 1, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19192
Drugs@FDA: Overview at FDA
Company: Wyeth Pharmaceuticals

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