Regulatory UpdatesAug 30, 2026•1 min read

FDA Approves ANDA077997 for Caffeine Citrate Intravenous Solution

By the PharmaCountry team

The FDA has granted approval for ANDA077997, an intravenous caffeine citrate solution manufactured by Fresenius Kabi USA, now listed as a prescription drug.

The U.S. Food and Drug Administration has approved application ANDA077997 for a caffeine citrate product. The product, marketed under the brand name Caffeine Citrate, is an intravenous solution containing 30 mg base per 3 mL (equivalent to 10 mg/mL). It is classified as a human prescription drug. Manufactured by Fresenius Kabi USA, LLC, the product is listed with NDC codes 63323-407-03 and 63323-407-04. The submission history includes an original submission on July 20, 2007 and labeling submissions on May 23, 2025 and September 16, 2025, all with standard review priority. The FDA’s approval adds the product to the market as a prescription intravenous therapy.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#caffeine citrate #intravenous #ANDA #FDA approval #prescription drug #Fresenius Kabi