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General MedicationsORALGeneric

ULTRACET

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Standard Dose
325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Discontinued
  • Approval overview ULTRACET is listed in Drugs@FDA under application 021123 (NDA).
  • Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2023-02-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview ULTRACET is listed in Drugs@FDA under application 021123 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE Form and strength TABLET;ORAL - 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JANSSEN PHARMS Submission history Latest submission status date: 2023-02-13 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.