FDA Approves CALCITRIOL Injection (ANDA078066)

FDA has approved an Abbreviated New Drug Application (ANDA) numbered 078066 for CALCITRIOL injectable products submitted by LONG GROVE PHARMS. The submission includes two injectable products. Product 001 is a prescription‑only CALCITRIOL injection at 0.001 mg/mL, listed as a reference standard. Product 002 is a discontinued CALCITRIOL injection at 0.002 mg/mL, not a reference standard. The original approval was issued on 29 January 2008 (submission type ORIG, status AP). A labeling supplement (submission type SUPPL, class code LABELING) was approved on 6 May 2013. Both products are administered via injection and are not designated as reference drugs.