Progesterone

As of Nov 13, 2026, NDA 9238 (Progesterone), held by Lilly, was first approved by FDA on Nov 1, 1974, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 1, 1974
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 17, 2001	Supplement 11Efficacy (new indication or use)	Approved	None posted
Sep 17, 2001	Supplement 8Efficacy (new indication or use)	Approved	None posted
Nov 1, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Progesterone50MG/ML · injectable;injection	Progesterone	Discontinued
Progesterone25MG/ML · injectable;injection	Progesterone	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 17, 2001	Supplement 11Efficacy (new indication or use)	Approved	None posted
Sep 17, 2001	Supplement 8Efficacy (new indication or use)	Approved	None posted
Sep 17, 2001	Supplement 7Labeling	Approved	None posted
Nov 16, 1984	Supplement 13Labeling	Approved	None posted
Mar 9, 1981	Supplement 12Labeling	Approved	None posted
Nov 1, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 9238
Drugs@FDA: Overview at FDA
Company: Lilly

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