Levora 0.15/30-21

ANDA 73592, held by Watson Labs. Ethinyl Estradiol; Levonorgestrel.

As of Nov 15, 2026, ANDA 73592 (Levora 0.15/30-21), held by Watson Labs, was first approved by FDA on Dec 13, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 13, 1993
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 13, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levora 0.15/30-210.03MG;0.15MG · tablet;oral-21	Ethinyl Estradiol; Levonorgestrel	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 22Labeling · Standard review	Approved	None posted
Mar 9, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 20Labeling · Standard review	Approved	None posted
Aug 16, 2001	Supplement 6Manufacturing	Approved	None posted
Oct 31, 1996	Supplement 3Manufacturing	Approved	None posted
Jul 10, 1996	Supplement 2Labeling	Approved	None posted
Jun 10, 1996	Supplement 1Manufacturing	Approved	None posted
Dec 13, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73592
Drugs@FDA: Overview at FDA
Company: Watson 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