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HYDROCODONE BITARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALVOGEN · Approved 2021-03-01

Drug application

FDA Application #

ANDA208269

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROCODONE BITARTRATE

Generic name

HYDROCODONE BITARTRATE

Active ingredients

HYDROCODONE BITARTRATE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

ALVOGEN

Manufacturer

Alvogen Inc.

First approval

2021-03-01

Source

Authoritative

Drugs@FDA application overview

Machine

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