Lupaneta Pack

NDA 203696, held by Abbvie Endocrine. Leuprolide Acetate; Norethindrone Acetate.

As of Nov 14, 2026, NDA 203696 (Lupaneta Pack), held by Abbvie Endocrine, was first approved by FDA on Dec 14, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2012
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Dec 14, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review

Products

2 strengths and forms


Lupaneta Pack3.75MG/VIAL,N/A;N/A,5MG · injectable, tablet;intramuscular, oral	Leuprolide Acetate; Norethindrone Acetate	DiscontinuedReference drug
Lupaneta Pack11.25MG/VIAL,N/A;N/A,5MG · injectable, tablet;intramuscular, oral	Leuprolide Acetate; Norethindrone Acetate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Aug 9, 2023	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 9, 2023	Supplement 6Labeling · Standard review	Approved	Letter Label Medication Guide
Jan 31, 2023	Supplement 7Labeling · Standard review	Approved	Label Letter
Apr 29, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 20, 2013	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 30, 2013	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 14, 2012	Original applicationNew combination · Standard review	Approved	Review Summary Review

Identifiers

Application: NDA 203696
Drugs@FDA: Overview at FDA
Company: AbbVie Endocrine

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