Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide
Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches Exenatide approval highlights Amneal’s capabilities in…
ANDA
Indoco Remedies receives final ANDA approval from USFDA for Varenicline Tablets, 0.5 mg and 1 mg
Indoco Remedies Ltd. announced the final approval of the Company’s Abbreviated NewDrug Application (ANDA) for Varenicline Tablets, 0.5…
Amneal Pharma Receives FDA Approval for Propofol Injectable Emulsion in Multiple Doses
Amneal Pharmaceuticals, Inc. announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food…
Abryl Laboratories Achieves Milestone with Regadenoson Injection ANDA Approval
Abryl Laboratories announced the approval of its Abbreviated New Drug Application (ANDA) for Regadenoson Injection in pre-filled syringes.…