← FDA Drug Approvals (Drugs@FDA)

APREMILAST

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2021-09-21

Drug application

FDA Application #

ANDA211761

Application type

Abbreviated New Drug Application (Generic)

Brand name

APREMILAST

Generic name

Apremilast

Active ingredients

APREMILAST

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

First approval

2021-09-21

Source

Authoritative

Drugs@FDA application overview

Machine

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