Regulatory UpdatesSep 8, 2026•1 min read

FDA Approves CALCITRIOL Injection (ANDA078066)

By the PharmaCountry team

FDA granted approval for CALCITRIOL injectable products (ANDA078066) from LONG GROVE PHARMS, including a prescription 0.001 mg/mL product and a discontinued 0.002 mg/mL version.

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.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #Calcitriol #injection #Long Grove Pharm #Regulatory Approval