← FDA Drug Approvals (Drugs@FDA)

ROFLUMILAST

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2022-02-10

Drug application

FDA Application #

ANDA208303

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

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2022-02-10

Source

Authoritative

Drugs@FDA application overview

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