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FDA NDA · NDA212595

RIOMET ER

Sponsor: SUN PHARM

APPLICATION
NDA212595
TYPE
NDA
ORIGINAL APPROVAL
2019-08-29
LATEST ACTION
2019-08-29
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

RIOMET ER · ReferenceDiscontinued
METFORMIN HYDROCHLORIDE 500MG/5ML · FOR SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2019-08-29Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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