General MedicationsORALGeneric

GLYNASE

GLYBURIDE

Standard Dose

4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Summary

Approval overview GLYNASE is listed in Drugs@FDA under application 020051 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYBURIDE Form and strength TABLET;ORAL - 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PFIZER Submission history Latest submission status date: 2017-08-22 00:00:00.

Structured Monograph

Clinical summary

Approval overview GLYNASE is listed in Drugs@FDA under application 020051 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYBURIDE Form and strength TABLET;ORAL - 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor PFIZER Submission history Latest submission status date: 2017-08-22 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.