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General MedicationsORALGeneric

VICOPROFEN

HYDROCODONE BITARTRATE; IBUPROFEN

Standard Dose
7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview VICOPROFEN is listed in Drugs@FDA under application 020716 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2016-12-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview VICOPROFEN is listed in Drugs@FDA under application 020716 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient HYDROCODONE BITARTRATE; IBUPROFEN Form and strength TABLET;ORAL - 7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ABBVIE Submission history Latest submission status date: 2016-12-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.