FDA Approves ANDA077903 for Zolpidem Tartrate

The U.S. Food and Drug Administration has approved the Abbreviated New Drug Application (ANDA) number ANDA077903 for Zolpidem Tartrate, manufactured by Torrent Pharmaceuticals Limited. The product is classified as a human prescription drug and is administered orally. The approved dosage forms are tablets containing 5 mg and 10 mg of Zolpidem Tartrate, identified as product numbers 001 and 002 respectively. Both strengths are marketed as prescription‑only medications. The approval follows a series of supplemental submissions (numbers 6, 17, 19, 23, 25, 27, and 29) primarily addressing labeling, with the most recent submission status recorded on November 29, 2019. The original application was submitted on August 17, 2007.