Treats dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to…. ANDA 210629, held by Lupin. Cyanocobalamin.
As of Nov 15, 2026, ANDA 210629 (Cyanocobalamin), held by Lupin, was first approved by FDA on Jun 30, 2023, with 0 approved supplements and 0 published complete response letters.
Cyanocobalamin Nasal Spray is indicated for: Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normal Limitations of Use: Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyanocobalamin0.5MG/SPRAY · spray, metered;nasal | 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
