US drug approvals
2 approvals with a product on the US market
- Cladribine ANDA215547 · approved 27 Mar 2026
- Sapropterin Dihydrochloride ANDA216432 · approved 3 Sep 2025
Source: Drugs@FDA, Approvals (NDA, ANDA, BLA) held, with a product sold now; newest shown. Retrieved 13 Nov 2026.