FDA Approves ANDA083022 for DODEX Injectable (Cyanocobalamin)

The FDA has granted approval for application number ANDA083022 submitted by ACCORD HLTHCARE. The submission pertains to DODEX, an injectable product (product number 001) with a dosage form of INJECTABLE. The product contains the active ingredient cyanocobalamin at a strength of 1 mg/mL. It is classified under route INJECTION and TE code AP. The reference drug status is No and the product is currently marked as discontinued. The original submission (submission number 1) received approval on September 20, 1972. A supplemental manufacturing (CMC) submission (submission number 10) was approved on November 4, 2024. No reference standard is listed for this product.