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General MedicationsORALStandard

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Standard Dose
300MG;5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview HYDROCODONE BITARTRATE AND ACETAMINOPHEN is listed in Drugs@FDA under application 209036 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE Form and strength TABLET;ORAL - 300MG;5MG Sponsor ABHAI LLC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYDROCODONE BITARTRATE AND ACETAMINOPHEN is listed in Drugs@FDA under application 209036 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE Form and strength TABLET;ORAL - 300MG;5MG Sponsor ABHAI LLC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.