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ACETAMINOPHEN AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GENUS LIFESCIENCES · Approved 1981-08-21

Drug application

FDA Application #

ANDA087508

Application type

Abbreviated New Drug Application (Generic)

Brand name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Generic name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Active ingredients

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

GENUS LIFESCIENCES

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

1981-08-21

Source

Authoritative

Drugs@FDA application overview

Machine

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