ANDA 215107, held by Sagent Pharms Inc. Cyanocobalamin.
As of Nov 15, 2026, ANDA 215107 (Cyanocobalamin), held by Sagent Pharms Inc, was first approved by FDA on Nov 15, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cyanocobalamin Injection 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/Laboratory Test Interactions ), us…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin1MG/ML · injectable;injection | Cyanocobalamin | Rx |
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
