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BUPROPION HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2014-01-17

Drug application

FDA Application #

ANDA201567

Application type

Abbreviated New Drug Application (Generic)

Brand name

BUPROPION HYDROCHLORIDE

Generic name

BUPROPION

Active ingredients

BUPROPION HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2014-01-17

Source

Authoritative

Drugs@FDA application overview

Machine

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