Regulatory UpdatesSep 2, 2026•1 min read

FDA Approves ANDA207047 for Clindamycin Palmitate Hydrochloride

By the PharmaCountry team

The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.

The U.S. Food and Drug Administration (FDA) granted approval for application number ANDA207047. The approved product is Clindamycin Palmitate Hydrochloride, an oral solution with a strength of equivalent 75 mg base per 5 ml. It is listed under the National Drug Code 23155-603-51 and is classified as a prescription human drug. The product is manufactured by Heritage Pharmaceuticals Inc., doing business as Avet Pharmaceuticals Inc., and the sponsor listed is APPCO. The submission was an original (ORIG) filing, received with standard review priority, and received an approved (AP) status on May 11, 2018. The dosage form is designated for oral administration, and the product is not a reference drug. Marketing status is prescription only.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #Clindamycin #oral solution #prescription drug #Heritage Pharmaceuticals