Aquamephyton

NDA 12223, held by Pai Holdings Pharm. Phytonadione.

As of Nov 13, 2026, NDA 12223 (Aquamephyton), held by Pai Holdings Pharm, was first approved by FDA on Jun 28, 1960, with 27 approved supplements and 0 published complete response letters.

First approved: Jun 28, 1960
Review: Standard
Supplements approved: 27
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 28 submissions below

Date	Submission	Status	Documents
Jun 28, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Aquamephyton10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Phytonadione	DiscontinuedReference drug
Aquamephyton1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Phytonadione	DiscontinuedReference drug

All 28 submissions, including labeling and manufacturing supplements


Nov 23, 2018	Supplement 42Labeling · Standard review	Approved	Label
Mar 7, 2018	Supplement 41Labeling · Standard review	Approved	Letter Label
May 25, 2017	Supplement 40Labeling · Standard review	Approved	Label Letter
Jun 4, 2003	Supplement 39Labeling · Standard review	Approved	Label Letter
Feb 27, 2003	Supplement 38Labeling · Standard review	Approved	Letter
Aug 16, 2001	Supplement 37Manufacturing · Standard review	Approved	None posted
May 18, 2001	Supplement 36Labeling · Standard review	Approved	Letter
Jul 14, 1998	Supplement 35Manufacturing · Standard review	Approved	None posted
May 28, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Jan 14, 1997	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 6, 1996	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 6, 1996	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 25, 1996	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 5, 1995	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 8, 1995	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 24, 1995	Supplement 27Labeling · Standard review	Approved	None posted
Jun 28, 1991	Supplement 26Labeling	Approved	None posted
Apr 26, 1990	Supplement 25Labeling	Approved	None posted
Aug 19, 1986	Supplement 21Labeling	Approved	None posted
Aug 27, 1985	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 11, 1984	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 18, 1982	Supplement 22Labeling	Approved	None posted
Nov 3, 1981	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 14, 1981	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 28, 1980	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 18, 1979	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 1, 1976	Supplement 16Manufacturing · Standard review	Approved	None posted
Jun 28, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12223
Drugs@FDA: Overview at FDA
Company: PAI Holdings Pharm

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