Vitamin K1

ANDA 87955, held by Hospira. Phytonadione.

As of Nov 15, 2026, ANDA 87955 (Vitamin K1), held by Hospira, was first approved by FDA on Jul 25, 1983, with 15 approved supplements and 0 published complete response letters.

First approved: Jul 25, 1983
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP) is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Vitamin K1 Injection is indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jul 25, 1983	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vitamin K110MG/ML · injectable;injection	Phytonadione	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Mar 6, 2026	Supplement 33Labeling · Standard review	Approved	None posted
Oct 7, 2004	Supplement 17Labeling	Approved	None posted
Feb 27, 2003	Supplement 15Labeling	Approved	None posted
Jul 19, 1999	Supplement 14Labeling	Approved	None posted
Nov 2, 1995	Supplement 12Manufacturing	Approved	None posted
Dec 2, 1993	Supplement 11Manufacturing	Approved	None posted
Aug 28, 1992	Supplement 10Labeling	Approved	None posted
Dec 28, 1989	Supplement 9Labeling	Approved	None posted
Aug 15, 1989	Supplement 8Manufacturing	Approved	None posted
May 19, 1989	Supplement 7Labeling	Approved	None posted
Feb 22, 1989	Supplement 6Labeling	Approved	None posted
Nov 4, 1988	Supplement 4Manufacturing	Approved	None posted
Nov 4, 1988	Supplement 5Manufacturing	Approved	None posted
Apr 27, 1984	Supplement 2Manufacturing	Approved	None posted
Dec 6, 1983	Supplement 1Manufacturing	Approved	None posted
Jul 25, 1983	Original application	Approved	Review

Identifiers

Application: ANDA 87955
Drugs@FDA: Overview at FDA
Company: Hospira

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