General MedicationsORALStandard

HYDROCODONE BITARTRATE AND IBUPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

Standard Dose

7.5MG;200MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview HYDROCODONE BITARTRATE AND IBUPROFEN is listed in Drugs@FDA under application 204575 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 7.5MG;200MG Sponsor AUROLIFE PHARMA LLC Submission history Latest submission status date: 2025-12-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYDROCODONE BITARTRATE AND IBUPROFEN is listed in Drugs@FDA under application 204575 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 7.5MG;200MG Sponsor AUROLIFE PHARMA 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.