Lupin Ltd Submits Original ANDA216716 to FDA – Tentative Approval

Lupin Ltd submitted an original Abbreviated New Drug Application (ANDA) identified as ANDA216716 to the U.S. Food and Drug Administration. The submission is recorded under a standard review priority and is classified as an original submission (submission number 1). The FDA status for this application is listed as "TA" (Tentative Approval) with the status date of August 13, 2024. No additional details about the product or approval timeline were provided in the source data.