← FDA Drug Approvals (Drugs@FDA)

ROFLUMILAST

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MICRO LABS · Approved 2019-03-22

Drug application

FDA Application #

ANDA208180

Application type

Abbreviated New Drug Application (Generic)

Brand name

ROFLUMILAST

Generic name

ROFLUMILAST

Active ingredients

ROFLUMILAST

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

MICRO LABS

Manufacturer

Micro Labs Limited

First approval

2019-03-22

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown