ANDA 217839, held by Mankind Pharma. Cyanocobalamin.
As of Nov 15, 2026, ANDA 217839 (Cyanocobalamin), held by Mankind Pharma, was first approved by FDA on Jul 10, 2024, with 1 approved supplement and 0 published complete response letters.
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-free diet in…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin1MG/ML · injectable;injection | Cyanocobalamin | Rx |
| Feb 7, 2025 | Supplement 3Manufacturing | Approved | None posted |
| Jul 10, 2024 | Original application | Approved | None posted |
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
