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General MedicationsORALGeneric

AVANDAMET

METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Standard Dose
1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: 901 REQUIRED Marketing status: Discontinued

Key Takeaways

  • Primary indication: Review priority: 901 REQUIRED Marketing status: Discontinued
  • Approval overview AVANDAMET is listed in Drugs@FDA under application 021410 (NDA).
  • Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Form and strength TABLET;ORAL - 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SB PHARMCO Submission history Latest submission status date: 2017-04-05 00:00:00.

Structured Monograph

Clinical summary

Approval overview AVANDAMET is listed in Drugs@FDA under application 021410 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE Form and strength TABLET;ORAL - 1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor SB PHARMCO Submission history Latest submission status date: 2017-04-05 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.