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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2013-05-10

Drug application

FDA Application #

ANDA040838

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

PHARM ASSOC

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

2013-05-10

Source

Authoritative

Drugs@FDA application overview

Machine

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