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General MedicationsORALStandard

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Standard Dose
325MG;50MG;40MG;30MG
Max Dose
Refer to approved labeling
Primary Use
Marketing status: Prescription
Summary

Approval overview BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 215138 (ANDA).

Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE Form and strength CAPSULE;ORAL - 325MG;50MG;40MG;30MG Sponsor HIKMA Submission history Latest submission status date: 2024-10-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE is listed in Drugs@FDA under application 215138 (ANDA). Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE Form and strength CAPSULE;ORAL - 325MG;50MG;40MG;30MG Sponsor HIKMA Submission history Latest submission status date: 2024-10-31 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE (ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE) | Drug Monograph | MedicHelpline