Prostin F2 Alpha

NDA 17434, held by Pharmacia And Upjohn. Dinoprost Tromethamine.

As of Nov 13, 2026, NDA 17434 (Prostin F2 Alpha), held by Pharmacia And Upjohn, was not approved, with 9 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 9
Complete response letters: 0

Products

1 strengths and forms

Product	Active ingredient	Marketing
Prostin F2 AlphaEQ 5MG BASE/ML · injectable;injection	Dinoprost Tromethamine	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 5, 1983	Supplement 16Manufacturing · Priority review	Approved	None posted
Dec 15, 1982	Supplement 15Labeling	Approved	None posted
Dec 29, 1981	Supplement 4Manufacturing · Priority review	Approved	None posted
Jun 17, 1981	Supplement 13Labeling	Approved	None posted
Mar 20, 1980	Supplement 12Labeling	Approved	None posted
Apr 13, 1979	Supplement 11Labeling	Approved	None posted
Sep 21, 1977	Supplement 10Labeling	Approved	None posted
May 18, 1976	Supplement 8Labeling	Approved	None posted
Dec 4, 1975	Supplement 7Labeling	Approved	None posted

Identifiers

Application: NDA 17434
Drugs@FDA: Overview at FDA
Company: Pharmacia & Upjohn

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