ANDA 214390, held by Gland. Cyanocobalamin.
As of Nov 15, 2026, ANDA 214390 (Cyanocobalamin), held by Gland, was first approved by FDA on Sep 24, 2020, with 3 approved supplements 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 |
|---|---|---|---|
| Sep 24, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin1MG/ML · injectable;injection | Cyanocobalamin | Rx |
| Jan 10, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 14, 2022 | Supplement 1Manufacturing | Approved | |
| Oct 14, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 24, 2020 | 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
