Vitamin K1

ANDA 87956, held by Hospira. Phytonadione.

As of Nov 15, 2026, ANDA 87956 (Vitamin K1), held by Hospira, was first approved by FDA on Jul 25, 1983, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 25, 1983
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 25, 1983	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Nov 2, 1995	Supplement 3Manufacturing	Approved	None posted
Apr 27, 1984	Supplement 2Manufacturing	Approved	None posted
Jul 25, 1983	Original application	Approved	None posted

Identifiers

Application: ANDA 87956
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