Phytonadione

Treats Hypoprothrombinemia. ANDA 83722, held by Intl Medication. Phytonadione.

As of Nov 15, 2026, ANDA 83722 (Phytonadione), held by Intl Medication, was first approved by FDA on Mar 1, 1976, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 1, 1976
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1.1 Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione Injectable Emulsion, USP is indicated for the treatment of 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; anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; 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 17 submissions below

Date	Submission	Status	Documents
Mar 1, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phytonadione1MG/0.5ML · injectable;injection	Phytonadione	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Oct 23, 2023	Supplement 34Manufacturing	Approved	Letter Label
Oct 23, 2023	Supplement 31Labeling · Standard review	Approved	Letter Label
Oct 23, 2023	Supplement 29Labeling · Standard review	Approved	Letter Label
Apr 18, 2003	Supplement 23Labeling	Approved	None posted
Mar 6, 2002	Supplement 21Labeling	Approved	None posted
Jan 4, 2001	Supplement 20Manufacturing	Approved	None posted
Jul 11, 2000	Supplement 5Manufacturing	Approved	None posted
Jan 14, 1998	Supplement 15Manufacturing	Approved	None posted
Sep 19, 1995	Supplement 19Manufacturing	Approved	None posted
Nov 10, 1994	Supplement 18Labeling	Approved	None posted
Jun 17, 1994	Supplement 16Manufacturing	Approved	None posted
Feb 3, 1994	Supplement 14Labeling	Approved	None posted
Oct 29, 1993	Supplement 13Manufacturing	Approved	None posted
Aug 30, 1993	Supplement 12Manufacturing	Approved	None posted
Dec 9, 1992	Supplement 11Labeling	Approved	Review
Aug 5, 1987	Supplement 9Manufacturing	Approved	Review
Mar 1, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 83722
Drugs@FDA: Overview at FDA
Company: International Medication Systems

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