Amneal

4 products tracked · names used in filings: Amneal, Amneal Pharms Llc, Amneal Pharma Europe Ltd

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Thu 09 Jul 2026🇺🇸 FDA approval

FDA approves Sodium Bicarbonate (sodium bicarbonate): new formulation or manufacturer

Amneal; NDA220790; New formulation or manufacturer; solution · source

Fri 19 Dec 2025🇺🇸 FDA approval

FDA approves biosimilar Boncresa (denosumab-mobz)

Amneal Pharms Llc; BLA761456; Biosimilar; injectable · source

Fri 19 Dec 2025🇺🇸 FDA approval

FDA approves biosimilar Oziltus (denosumab-mobz)

Amneal Pharms Llc; BLA761457; Biosimilar; injectable · source

Products

ProductStatusApproved
🇺🇸Sodium Bicarbonate
sodium bicarbonate
Approved2026-07-09
🇺🇸Boncresa
denosumab-mobz
Approved2025-12-19
🇺🇸Oziltus
denosumab-mobz
Approved2025-12-19
🇪🇺Numient
levodopa;carbidopa
Withdrawn2015-11-19

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.