General MedicationsORALStandard

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Standard Dose

325MG/15ML;10MG/15ML

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 040834 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE Form and strength SOLUTION;ORAL - 325MG/15ML;10MG/15ML Sponsor PHARM ASSOC 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 040834 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETAMINOPHEN; HYDROCODONE BITARTRATE Form and strength SOLUTION;ORAL - 325MG/15ML;10MG/15ML Sponsor PHARM ASSOC 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.