Innovation

Product

  • Project 301: Fixed combination extended-release tablet

  • Project 306: Fixed combination extended-release tablet

  • Project 308: Fixed combination extended-release tablet

  • Project 309: Extended-release tablet

Indication

  • Treatment for type 2 diabetes

  • Treatment for type 2 diabetes

  • Treatment for type 2 diabetes

  • Treatment for type 2 diabetes

Approval Status

  • NDA filing Stage

  • IND under FDA review

  • IND under FDA review

  • IND under FDA review

Prescription Information

  • Not available

  • Not available

  • Not available

  • Not available

Generic

Product

  • Generic of Tegretol XR (Carbamazepine Extended-Release Tablet)

  • Generic of Plaquenil (Hydroxychloroquine Sulfate Tablet)

  • Generic of Toprol XL (Metoprolol Succinate Extended-Release Tablet)

  • Generic of Procardia XL (Nifedipine Extended-Release Tablet)

  • Generic of Invega (Paliperidone Extended-Release Tablet)

  • Generic of Valcyte (Valganciclovir Hydrochloride Tablet)

Indication

  • Treatment for epilepsy and trigeminal neuralgia

  • Treatment for uncomplicated malaria

  • Treatment for hypertension, angina pectoris, and heart failure

  • Management for vasospastic angina, chronic stable angina, and hypertension

  • Treatment for schizophrenia

  • Treatment for cytomegalovirus (CMV) retinitis and prevention of CMV disease

Approval Status

  • US FDA Approval 04/13/2021

  • NMPA Approval 12/21/2021

  • NMPA Approval 09/30/2021

  • US FDA Approval 07/26/2024

  • US FDA Approval 11/18/2020

  • US FDA Approval 10/29/2020

  • NMPA Approval 06/07/2023

  • NMPA Approval 06/28/2024

  • US FDA Approval 04/16/2025

Prescription Information

To report suspected adverse reactions, contact the FDA at (800) FDA-1088 or www.fda.gov/medwatch