Sigmapharm files an Abbreviated New Drug Application (ANDA No. 210053) which includes a Paragraph-IV certification (our 8th Paragraph-IV filing).
- Sigmapharm receives FDA approval for generic Potassium Chloride Extended-Release Tablets, USP 8 mEq (600 mg) and 10 mEq (750 mg), based on its ANDA No. 207528.
- Sigmapharm files a Drug Master File for Amorphous Apixaban (Type II DMF No. 030774).
Sigmapharm successfully completes an FDA inspection focused on a Pre-Approval-Inspection related to its ANDA No. 207528.