Hemabate

Treats postpartum hemorrhage due to uterine atony. NDA 17989, held by Pfizer. Carboprost Tromethamine.

As of Nov 13, 2026, NDA 17989 (Hemabate), held by Pfizer, was first approved by FDA on Jan 9, 1979, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 9, 1979
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE HEMABATE Sterile Solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 9, 1979	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
HemabateEQ 0.25MG BASE/ML · injectable;injection	Carboprost Tromethamine	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 19, 2015	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 9, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 11, 2013	Supplement 19Labeling · Standard review	Approved	Label Letter
Oct 15, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 3, 2000	Supplement 13Manufacturing · Standard review	Approved	None posted
May 11, 1998	Supplement 12Labeling · Standard review	Approved	None posted
Aug 29, 1995	Supplement 10Labeling · Standard review	Approved	None posted
Aug 29, 1995	Supplement 11Labeling · Standard review	Approved	None posted
May 8, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 3, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 21, 1988	Supplement 7Labeling	Approved	None posted
Sep 8, 1986	Supplement 6Labeling	Approved	None posted
May 21, 1985	Supplement 5Labeling	Approved	None posted
Aug 30, 1983	Supplement 4Labeling	Approved	None posted
Dec 29, 1981	Supplement 3Labeling	Approved	None posted
Mar 10, 1981	Supplement 1Labeling	Approved	None posted
Mar 20, 1980	Supplement 2Labeling	Approved	None posted
Jan 9, 1979	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 17989
Drugs@FDA: Overview at FDA
Company: Pfizer

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