Plan B

NDA 21045, held by Fdn Consumer. Levonorgestrel.

As of Nov 14, 2026, NDA 21045 (Plan B), held by Fdn Consumer, was first approved by FDA on Jul 28, 1999, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1999
Review: Priority
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Jul 10, 2009	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 24, 2006	Supplement 11Efficacy (new indication or use)	Approved	Review Letter Label
Jul 28, 1999	Original applicationTYPE 3/4 · Priority review	Approved	Label Letter Review

Products

2 strengths and forms


Plan B0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levonorgestrel	DiscontinuedReference drug
Plan B0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Levonorgestrel	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Mar 21, 2024	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 24, 2018	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 28, 2017	Supplement 16Labeling · Standard review	Approved	Label Letter
Jul 10, 2009	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 24, 2006	Supplement 11Efficacy (new indication or use)	Approved	Review Letter Label
Jun 21, 2002	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 13, 2002	Supplement 7Manufacturing · Priority review	Approved	None posted
Feb 28, 2001	Supplement 6Manufacturing · Priority review	Approved	None posted
Dec 13, 2000	Supplement 5Manufacturing · Priority review	Approved	None posted
Jun 30, 2000	Supplement 3Manufacturing · Priority review	Approved	None posted
May 24, 2000	Supplement 4Manufacturing · Priority review	Approved	None posted
Apr 12, 2000	Supplement 2Manufacturing · Priority review	Approved	None posted
Mar 28, 2000	Supplement 1Manufacturing · Priority review	Approved	None posted
Jul 28, 1999	Original applicationTYPE 3/4 · Priority review	Approved	Label Letter Review

Identifiers

Application: NDA 21045
Drugs@FDA: Overview at FDA
Company: FDN Consumer

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