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ACETAMINOPHEN AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ELITE LABS INC · Approved 2019-09-10

Drug application

FDA Application #

ANDA212418

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

ELITE LABS INC

Manufacturer

Elite Laboratories, Inc.

First approval

2019-09-10

Source

Authoritative

Drugs@FDA application overview

Machine

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