← FDA Drug Approvals (Drugs@FDA)

ENTACAPONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2017-08-31

Drug application

FDA Application #

ANDA205792

Application type

Abbreviated New Drug Application (Generic)

Brand name

ENTACAPONE

Generic name

ENTACAPONE

Active ingredients

ENTACAPONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AJANTA PHARMA LTD

Manufacturer

Ajanta Pharma USA Inc.

First approval

2017-08-31

Source

Authoritative

Drugs@FDA application overview

Machine

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