Cyanocobalamin, Vibisone

ANDA 80557, held by Fresenius Kabi USA. Cyanocobalamin.

As of Nov 15, 2026, ANDA 80557 (Cyanocobalamin, Vibisone), held by Fresenius Kabi USA, was first approved by FDA on Jun 20, 1973, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 20, 1973
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cyanocobalamin is indicated for Vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions ), use of a gl…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 20, 1973	Original application	Approved	None posted

Products

2 strengths and forms


Cyanocobalamin0.1MG/ML · injectable;injection	Cyanocobalamin	Discontinued
Vibisone1MG/ML · injectable;injection	Cyanocobalamin	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Jul 14, 2005	Supplement 32Labeling	Approved	None posted
Jun 25, 2001	Supplement 25Manufacturing	Approved	None posted
Jan 8, 1999	Supplement 29Manufacturing	Approved	None posted
Jul 14, 1995	Supplement 28Manufacturing	Approved	None posted
Nov 23, 1994	Supplement 27Manufacturing	Approved	None posted
Sep 28, 1990	Supplement 24Labeling	Approved	None posted
Sep 16, 1985	Supplement 19Manufacturing	Approved	None posted
Jun 15, 1983	Supplement 18Manufacturing	Approved	None posted
May 17, 1982	Supplement 11Manufacturing	Approved	None posted
May 17, 1982	Supplement 12Manufacturing	Approved	None posted
Jun 20, 1973	Original application	Approved	None posted

Identifiers

Application: ANDA 80557
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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