Dicopac Kit

NDA 17406, held by Ge Healthcare. Cyanocobalamin; Cyanocobalamin Co-57; Cyanocobalamin Co-58.

As of Nov 13, 2026, NDA 17406 (Dicopac Kit), held by Ge Healthcare, was first approved by FDA on Jun 10, 1974, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 10, 1974
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 10, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dicopac KitN/A;N/A;N/A · n/a;n/a	Cyanocobalamin; Cyanocobalamin Co-57; Cyanocobalamin Co-58	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Aug 5, 1994	Supplement 7Labeling · Standard review	Approved	None posted
Jan 16, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
May 30, 1978	Supplement 3Labeling · Standard review	Approved	None posted
Oct 13, 1976	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 10, 1974	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17406
Drugs@FDA: Overview at FDA
Company: GE Healthcare

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