Synkayvite

NDA 3718, held by Roche. Menadiol Sodium Diphosphate.

As of Nov 13, 2026, NDA 3718 (Synkayvite), held by Roche, was first approved by FDA on Jul 15, 1941, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1941
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 15, 1941	Original application	Approved	None posted

Products

4 strengths and forms


Synkayvite5MG/ML · injectable;injection	Menadiol Sodium Diphosphate	Discontinued
Synkayvite10MG/ML · injectable;injection	Menadiol Sodium Diphosphate	Discontinued
Synkayvite37.5MG/ML · injectable;injection	Menadiol Sodium Diphosphate	Discontinued
Synkayvite5MG · tablet;oral	Menadiol Sodium Diphosphate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 27, 1996	Supplement 4Labeling	Approved	None posted
Mar 27, 1996	Supplement 7Labeling	Approved	None posted
Sep 8, 1987	Supplement 8Labeling	Approved	None posted
Jul 15, 1941	Original application	Approved	None posted

Identifiers

Application: NDA 3718
Drugs@FDA: Overview at FDA
Company: Roche

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