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General MedicationsORALGeneric

HYDROCODONE BITARTRATE AND IBUPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

Standard Dose
5MG;200MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview HYDROCODONE BITARTRATE AND IBUPROFEN is listed in Drugs@FDA under application 091633 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 5MG;200MG Sponsor SUN PHARM INDS INC 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 091633 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 5MG;200MG Sponsor SUN PHARM INDS INC Submission history Latest submission status date: 2025-12-22 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.