Regulatory UpdatesSep 22, 2026•1 min read

FDA Issues Tentative Approval for Atomoxetine Hydrochloride Capsules (ANDA078940)

By the PharmaCountry team

The FDA has granted tentative approval for six oral capsule strengths of atomoxetine hydrochloride under ANDA078940, sponsored by Actavis Elizabeth.

The U.S. Food and Drug Administration (FDA) has issued a tentative approval for an Abbreviated New Drug Application (ANDA) identified as ANDA078940. The application covers oral capsule formulations of atomoxetine hydrochloride. The approved product list includes six strengths: 18 mg (product number 002), 25 mg (003), 40 mg (004), 60 mg (005), 80 mg (006), and 100 mg (007). All products are designated as "None (Tentative Approval)" for marketing status and are not reference drugs or reference standards. The original submission (type ORIG, submission number 1) received a tentative approval status (TA) on May 11, 2012. The sponsor for this ANDA is Actavis Elizabeth.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA078940 #atomoxetine #Tentative Approval #Oral Capsules #pharma regulation