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TYLENOL W/ CODEINE NO. 3

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ORTHO MCNEIL PHARM · Approved 1981-09-29

Drug application

FDA Application #
ANDA087422
Application type
Abbreviated New Drug Application (Generic)
Brand name
TYLENOL W/ CODEINE NO. 3
Generic name
Acetaminophen
Active ingredients
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Discontinued
Sponsor
ORTHO MCNEIL PHARM
First approval
1981-09-29

Source

Authoritative
Drugs@FDA application overview
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