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General MedicationsORALGeneric

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Standard Dose
300MG;50MG;40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is listed in Drugs@FDA under application 215135 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE Form and strength CAPSULE;ORAL - 300MG;50MG;40MG Sponsor HIKMA Submission history Latest submission status date: 2022-03-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is listed in Drugs@FDA under application 215135 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE Form and strength CAPSULE;ORAL - 300MG;50MG;40MG Sponsor HIKMA Submission history Latest submission status date: 2022-03-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.