FDA requested companies stop distributing unapproved versions of ascorbic acid injection.

The agency approved McGuff Pharmaceuticals Inc.’s Ascor (ascorbic acid injection), 500 mg/mL, 50 mL vial (NDC 67175-0101) on October 2, 2017. All other ascorbic acid injection products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:

FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drugs marketed in the United States.