← FDA Drug Approvals (Drugs@FDA)

APREMILAST

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2022-02-03

Drug application

FDA Application #
ANDA211859
Application type
Abbreviated New Drug Application (Generic)
Brand name
APREMILAST
Generic name
Apremilast
Active ingredients
APREMILAST
Dosage form
TABLET
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
ZYDUS PHARMS
First approval
2022-02-03

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown