Fallback Solo

ANDA 201446, held by Lupin. Levonorgestrel.

As of Nov 13, 2026, ANDA 201446 (Fallback Solo), held by Lupin, was first approved by FDA on Jun 19, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 19, 2014
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Indications Use for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 19, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fallback Solo1.5MG · tablet;oral	Levonorgestrel	OTC

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 1, 2026	Supplement 3Labeling · Standard review	Approved	None posted
May 1, 2026	Supplement 6Labeling · Standard review	Approved	None posted
May 1, 2026	Supplement 9Labeling · Standard review	Approved	None posted
May 13, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jun 19, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 201446
Drugs@FDA: Overview at FDA
Company: Lupin

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