Granules India announced that the US FDA has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg Tablets, Extended Release, bioequivalent to the reference listed drug product (RiD), Tylenol 650mg tablets, Extended Release.
The ANDA was filed by Granules Pharmaceuticals Inc, a wholly owned subsidiary of Granules lndia.
Acetaminophen 650 mg extended release tablets are. used primarily for temporary pain management including arthritis relief