DICOPAC KIT

The FDA’s NDA017406 record pertains to the product DICOPAC KIT, marketed by GE Healthcare. The product’s marketing status is listed as discontinued. Active ingredients in DICOPAC KIT include CYANOCOBALAMIN, CYANOCOBALAMIN CO-57, and CYANOCOBALAMIN CO-58. The product is not a reference drug and does not have a reference standard. Product details such as route and dosage form are not applicable, and the product number is 001. Submission history for this NDA includes: - Original submission (Type 5 – New Formulation or New Manufacturer) submitted on 1974-06-10, status AP. - Manufacturing (CMC) submission on 1976-10-13, status AP. - Labeling submission on 1978-05-30, status AP. - Manufacturing (CMC) submission on 1991-01-16, status AP. - Labeling submission on 1994-08-05, status AP. - Additional labeling submission on 1994-08-05, status AP. All submissions were reviewed with standard priority. The record provides a concise view of the product’s regulatory timeline and composition.