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ACETAMINOPHEN AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIBROW HLTHCARE · Approved 2019-06-27

Drug application

FDA Application #

ANDA211610

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

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

HIBROW HLTHCARE

Manufacturer

Eywa Pharma Inc

First approval

2019-06-27

Source

Authoritative

Drugs@FDA application overview

Machine

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