← FDA Drug Approvals (Drugs@FDA)

ROFLUMILAST

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2018-11-23

Drug application

FDA Application #

ANDA208213

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

HETERO LABS LTD III

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2018-11-23

Source

Authoritative

Drugs@FDA application overview

Machine

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