Cyanocobalamin

ANDA 80554, held by Wyeth Ayerst. Cyanocobalamin.

As of Nov 15, 2026, ANDA 80554 (Cyanocobalamin), held by Wyeth Ayerst, was first approved by FDA on Mar 21, 1973, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 21, 1973
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
Mar 21, 1973	Original application	Approved	None posted

Products

2 strengths and forms


Cyanocobalamin0.1MG/ML · injectable;injection	Cyanocobalamin	Discontinued
Cyanocobalamin1MG/ML · injectable;injection	Cyanocobalamin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jun 2, 1995	Supplement 2Manufacturing	Approved	None posted
Jul 30, 1993	Supplement 1Manufacturing	Approved	None posted
Mar 21, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80554
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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