FDA Approves Labeling Updates for Granisetron Injection (ANDA078564)

The U.S. Food and Drug Administration (FDA) has issued approval for labeling supplements associated with ANDA078564. The application concerns GRANISETRON HYDROCHLORIDE, an injectable product marketed by Wockhardt USA. The product is listed as discontinued and was originally approved under submission type ORIG on June 30, 2008. Subsequent labeling supplements were submitted and approved on September 18, 2014, and February 25, 2015, both classified under the LABELING submission class. Granisetron Hydrochloride is presented as an injectable dosage form with a strength of EQ 1 mg base per milliliter. No reference drug or reference standard was identified for this ANDA. The sponsor, Wockhardt USA, remains the responsible party for the product. These approvals reflect standard regulatory updates to the product’s labeling information, despite its discontinued marketing status.