Regulatory UpdatesSep 11, 2026•1 min read

FDA Approves Lupin’s DOXERCALCIFEROL Injection (ANDA210801)

By the PharmaCountry team

The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #Injectable #DOXERCALCIFEROL #Lupin #approval