ANDA 206503, held by Somerset Theraps LLC. Cyanocobalamin.
As of Nov 15, 2026, ANDA 206503 (Cyanocobalamin), held by Somerset Theraps LLC, was first approved by FDA on Dec 11, 2015, 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 bacterial 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 ), use of a gl…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin1MG/ML · injectable;injection | Cyanocobalamin | Rx |
| Oct 21, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 21, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 21, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 11, 2015 | 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
