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CEVIMELINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2016-12-30

Drug application

FDA Application #

ANDA204746

Application type

Abbreviated New Drug Application (Generic)

Brand name

CEVIMELINE HYDROCHLORIDE

Generic name

CEVIMELINE HYDROCHLORIDE

Active ingredients

CEVIMELINE HYDROCHLORIDE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVEL LABS INC

Manufacturer

Lupin Pharmaceuticals,Inc.

First approval

2016-12-30

Source

Authoritative

Drugs@FDA application overview

Machine

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