FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)

The U.S. Food and Drug Administration has issued an approval for the abbreviated new drug application (ANDA) number ANDA210801, covering Lupin’s injectable product DOXERCALCIFEROL. The product is an injectable dosage form containing 4 mcg of DOXERCALCIFEROL in 2 ml (2 mcg/ml). The submission was classified as an original (ORIG) standard priority application and received an "AP" status on November 1, 2018. The FDA listing indicates the product’s marketing status as discontinued. No reference drug or reference standard is associated with this submission.