General MedicationsORALGeneric

FORTAMET

METFORMIN HYDROCHLORIDE

Standard Dose

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 FORTAMET is listed in Drugs@FDA under application 021574 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ANDRX LABS LLC Submission history Latest submission status date: 2018-11-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview FORTAMET is listed in Drugs@FDA under application 021574 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient METFORMIN HYDROCHLORIDE Form and strength TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ANDRX LABS LLC Submission history Latest submission status date: 2018-11-08 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.