Kariva

Prevents pregnancy. ANDA 75863, held by Barr. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 75863 (Kariva), held by Barr, was first approved by FDA on Apr 5, 2002, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 5, 2002
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Kariva (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 5, 2002	Original application	Approved	Letter Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kariva0.15MG,N/A;0.02MG,0.01MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Rx

All 10 submissions, including labeling and manufacturing supplements


Jun 10, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Jun 10, 2024	Supplement 35Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 34Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 26Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 21Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 20Labeling · Standard review	Approved	None posted
Sep 24, 2009	Supplement 15Labeling	Approved	None posted
Oct 4, 2002	Supplement 2Manufacturing	Approved	None posted
Oct 4, 2002	Supplement 1Manufacturing	Approved	None posted
Apr 5, 2002	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 75863
Drugs@FDA: Overview at FDA
Company: Barr 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