Cyanocobalamin

ANDA 80515, held by West-Ward Pharms Int. Cyanocobalamin.

As of Nov 15, 2026, ANDA 80515 (Cyanocobalamin), held by West-Ward Pharms Int, was first approved by FDA on Oct 20, 1971, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1971
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS & USAGE Cyanocobalamin is indicated for vitamin B12 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 bacteria 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 PRECAUTIONS- Drug Interactions), use of a gluten-fre…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 20, 1971	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cyanocobalamin1MG/ML · injectable;injection	Cyanocobalamin	Rx

All 15 submissions, including labeling and manufacturing supplements


Jan 4, 2016	Supplement 201Manufacturing	Approved	None posted
Oct 27, 2000	Supplement 200Manufacturing	Approved	None posted
Oct 16, 1998	Supplement 199Manufacturing	Approved	None posted
Sep 8, 1997	Supplement 196Manufacturing	Approved	None posted
Nov 18, 1993	Supplement 195Manufacturing	Approved	None posted
Apr 5, 1990	Supplement 194Labeling	Approved	None posted
May 9, 1989	Supplement 193Labeling	Approved	None posted
Apr 26, 1989	Supplement 192Labeling	Approved	None posted
Apr 26, 1989	Supplement 191Labeling	Approved	None posted
Apr 3, 1989	Supplement 190Labeling	Approved	None posted
Nov 3, 1986	Supplement 187Manufacturing	Approved	None posted
Nov 3, 1986	Supplement 184Manufacturing	Approved	None posted
Sep 10, 1986	Supplement 185Manufacturing	Approved	None posted
Feb 3, 1983	Supplement 182Manufacturing	Approved	None posted
Oct 20, 1971	Original application	Approved	Review

Identifiers

Application: ANDA 80515
Drugs@FDA: Overview at FDA
Company: West-Ward Pharms Int

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