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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WES PHARMA INC · Approved 2019-03-08

Drug application

FDA Application #

ANDA211023

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Generic name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Active ingredients

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

WES PHARMA INC

Manufacturer

Eywa Pharma Inc

First approval

2019-03-08

Source

Authoritative

Drugs@FDA application overview

Machine

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