Orange Book product · Brand (NDA)

RIOMET ER

METFORMIN HYDROCHLORIDE

Brand (NDA)NDA 212595DISCN SUN PHARM

Aug 29, 2019

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 29, 2019
6 yr 11 mo ago
Today
Patent 9962336 expires
Listed drug product patent expiration.
May 01, 2035
in 9 yr

Active ingredient

METFORMIN HYDROCHLORIDE

Strength

500MG/5ML

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 212595

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9962336	May 01, 2035	in 9 yr	Product