Regulatory UpdatesSep 4, 2026•1 min read

FDA Approves ANDA078948 for Ibandronate Sodium Tablet

By the PharmaCountry team

The FDA has approved ANDA078948 for a prescription oral tablet of Ibandronate Sodium 150 mg, sponsored by Apotex and manufactured by Golden State Medical Supply.

The U.S. Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) number 078948 covering Ibandronate Sodium tablets. The product is marketed under the brand name Ibandronate Sodium and is an oral tablet containing an equivalent of 150 mg ibandronate sodium base. It is classified as a human prescription drug. Apotex Inc. is listed as the sponsor, while Golden State Medical Supply, Inc. is identified as the manufacturer. The product’s National Drug Code (NDC) is 60429-643-73. The FDA submission record shows multiple labeling approvals, including recent submissions on 2023‑10‑27 (submission 9) and 2023‑06‑23 (submission 8), as well as earlier approvals on 2015‑07‑24 (submissions 2, 5, 6) and the original approval on 2012‑03‑19 (submission 1). A future‑dated labeling submission (submission 14) is listed for 2026‑02‑03.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Ibandronate Sodium #ANDA #FDA approval #prescription drug #Oral Tablet