Ortho Tri-Cyclen 21, Ortho Tri-Cyclen 28

NDA 21690, held by Ortho Mcneil Pharm. Ethinyl Estradiol; Norgestimate.

As of Nov 14, 2026, NDA 21690 (Ortho Tri-Cyclen 21, Ortho Tri-Cyclen 28), held by Ortho Mcneil Pharm, was first approved by FDA on May 13, 2005, with 1 approved supplement and 0 published complete response letters.

First approved: May 13, 2005
Review: Priority
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 13, 2005	Original applicationTYPE 6 · Priority review	Approved	Review Letter Label Patient Package Insert

Products

2 strengths and forms


Ortho Tri-Cyclen 210.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG · tablet; oral-21	Ethinyl Estradiol; Norgestimate	Rx
Ortho Tri-Cyclen 280.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG · tablet; oral-28	Ethinyl Estradiol; Norgestimate	Rx

All 2 submissions, including labeling and manufacturing supplements


May 1, 2015	Supplement 1Labeling · Standard review	Approved	Letter Label
May 13, 2005	Original applicationTYPE 6 · Priority review	Approved	Review Letter Label Patient Package Insert

Identifiers

Application: NDA 21690
Drugs@FDA: Overview at FDA
Company: Ortho-McNeil Pharmaceutical

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