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FDA ANDA · ANDA085056

TYLENOL W/ CODEINE

Sponsor: ORTHO MCNEIL PHARM

APPLICATION
ANDA085056
TYPE
ANDA
ORIGINAL APPROVAL
1976-07-09
LATEST ACTION
1976-07-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TYLENOL W/ CODEINEDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TYLENOL W/ CODEINEDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TYLENOL W/ CODEINEDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TYLENOL W/ CODEINEDiscontinued
ACETAMINOPHEN 325MG, CODEINE PHOSPHATE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

1976-07-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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