FDA Approves ANDA 076815 for Diazepam Injectable

The U.S. Food and Drug Administration (FDA) has issued an approval for ANDA 076815, submitted by Parenta Pharms. The application concerns a diazepam injectable product (5 mg/mL) intended for injection. The product is listed with a marketing status of “Discontinued”. The submission was an original (ORIG) application, received on April 15, 2004, with the approval letter dated April 20, 2004 (document ID 31167). The FDA’s submission status is “AP” (approved). For full details, refer to the FDA approval letter at the provided URL.