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Last Updated: August 4, 2020

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Details for New Drug Application (NDA): 212595

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NDA 212595 describes RIOMET ER, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RIOMET ER profile page.

The generic ingredient in RIOMET ER is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 212595
Tradename:RIOMET ER
Applicant:Sun Pharm
Ingredient:metformin hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 212595
Medical Subject Heading (MeSH) Categories for 212595
Suppliers and Packaging for NDA: 212595
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIOMET ER metformin hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 212595 NDA Sun Pharmaceutical Industries Inc. 10631-019 10631-019-17 473 mL in 1 BOTTLE (10631-019-17)

Profile for product number 001

Approval Date:Aug 29, 2019TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 1, 2035Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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