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General MedicationsORALGeneric

TYLENOL W/ CODEINE

ACETAMINOPHEN; CODEINE PHOSPHATE

Standard Dose
325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Discontinued
Summary

Approval overview TYLENOL W/ CODEINE is listed in Drugs@FDA under application 085056 (ANDA).

Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ORTHO MCNEIL PHARM Submission history Latest submission status date: 1976-07-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview TYLENOL W/ CODEINE is listed in Drugs@FDA under application 085056 (ANDA). Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 325MG;15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ORTHO MCNEIL PHARM Submission history Latest submission status date: 1976-07-09 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued

Interaction Notes

  • No interaction notes stored yet.