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Treats dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to…. ANDA 212458, held by Padagis Israel. Cyanocobalamin.
As of Nov 15, 2026, ANDA 212458 (Cyanocobalamin), held by Padagis Israel, was first approved by FDA on Sep 9, 2020, with 0 approved supplements and 0 published complete response letters.
First approved: Sep 9, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Cyanocobalamin Nasal Spray is indicated for:
Vitamin B 12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B 12 therapy and who have no nervous system involvement
Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B 12 deficiency not due to pernicious anemia
Prevention of vitamin B 12 deficiency in adult patients with vitamin B 12 requirements in excess of normal Limitations of Use
Cyanocobalamin Nasal Spray should not be used for the vitamin B 12 absorption test (Schilling test).
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
