Astramorph Pf

ANDA 71050, held by Fresenius Kabi USA. Morphine Sulfate.

As of Nov 15, 2026, ANDA 71050 (Astramorph Pf), held by Fresenius Kabi USA, was first approved by FDA on Oct 7, 1986, with 8 approved supplements and 0 published complete response letters.

First approved: Oct 7, 1986
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Oct 7, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Astramorph Pf0.5MG/ML · injectable;injection	Morphine Sulfate	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Oct 21, 2005	Supplement 10Labeling	Approved	None posted
Sep 30, 2004	Supplement 9Labeling	Approved	None posted
Oct 2, 2002	Supplement 8Labeling	Approved	None posted
Dec 12, 1997	Supplement 6Manufacturing	Approved	None posted
Jul 2, 1996	Supplement 5Manufacturing	Approved	None posted
Dec 20, 1988	Supplement 1Manufacturing	Approved	None posted
Dec 20, 1988	Supplement 2Manufacturing	Approved	None posted
Dec 20, 1988	Supplement 3Labeling	Approved	None posted
Oct 7, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 71050
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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