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General MedicationsORALGeneric

TYLENOL W/ CODEINE NO. 1

ACETAMINOPHEN; CODEINE PHOSPHATE

Standard Dose
300MG;7.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview TYLENOL W/ CODEINE NO. 1 is listed in Drugs@FDA under application 085055 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 300MG;7.5MG Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2019-11-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview TYLENOL W/ CODEINE NO. 1 is listed in Drugs@FDA under application 085055 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CODEINE PHOSPHATE Form and strength TABLET;ORAL - 300MG;7.5MG Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2019-11-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.