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General MedicationsORALGeneric

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Standard Dose
325MG;30MG;16MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE is listed in Drugs@FDA under application 204209 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE Form and strength TABLET;ORAL - 325MG;30MG;16MG Sponsor PHARMOBEDIENT Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE is listed in Drugs@FDA under application 204209 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE Form and strength TABLET;ORAL - 325MG;30MG;16MG Sponsor PHARMOBEDIENT Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.