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As of Nov 15, 2026, ANDA 213874 (Cyanocobalamin), held by Eugia Pharma, was first approved by FDA on Dec 8, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Dec 8, 2020
Review: Standard
Supplements approved: 1
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 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 Drug Interactions ), use of a gluten-fr…
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
