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General MedicationsORALStandard

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Standard Dose
325MG/15ML;50MG/15ML;40MG/15ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is listed in Drugs@FDA under application 040387 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE Form and strength SOLUTION;ORAL - 325MG/15ML;50MG/15ML;40MG/15ML Sponsor GENUS Submission history Latest submission status date: 2013-10-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is listed in Drugs@FDA under application 040387 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE Form and strength SOLUTION;ORAL - 325MG/15ML;50MG/15ML;40MG/15ML Sponsor GENUS Submission history Latest submission status date: 2013-10-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.