Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALStandard

BUTALBITAL AND ACETAMINOPHEN

ACETAMINOPHEN; BUTALBITAL

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

Approval overview BUTALBITAL AND ACETAMINOPHEN is listed in Drugs@FDA under application 213115 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL Form and strength CAPSULE;ORAL - 300MG;50MG Sponsor GRANULES Submission history Latest submission status date: 2019-11-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUTALBITAL AND ACETAMINOPHEN is listed in Drugs@FDA under application 213115 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; BUTALBITAL Form and strength CAPSULE;ORAL - 300MG;50MG Sponsor GRANULES Submission history Latest submission status date: 2019-11-22 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

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