FDA Approves ANDA078979 for DIVALPROEX SODIUM

The U.S. Food and Drug Administration has granted approval for ANDA078979, covering the generic drug DIVALPROEX SODIUM. The product is an oral, delayed‑release capsule (pellet formulation) marketed under the brand name DIVALPROEX SODIUM. Manufacturers listed for this ANDA are NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd. The product is available in several NDC codes, including 72603‑260‑01, 72603‑260‑02, 55111‑532‑30, 55111‑532‑01, 55111‑532‑05, 55111‑532‑79, and 55111‑532‑78, reflecting multiple package configurations. The FDA submission history shows a series of labeling supplements that have been approved (status “AP”) on dates ranging from 2011‑01‑21 to 2023‑10‑11, indicating ongoing updates to the product’s labeling information.