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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 021591


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NDA 021591 describes RIOMET, which is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the RIOMET profile page.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 021591
Tradename:RIOMET
Applicant:Ranbaxy
Ingredient:metformin hydrochloride
Patents:0
Pharmacology for NDA: 021591
Medical Subject Heading (MeSH) Categories for 021591
Suppliers and Packaging for NDA: 021591
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIOMET metformin hydrochloride SOLUTION;ORAL 021591 NDA Sun Pharmaceutical Industries, Inc. 10631-206 10631-206-01 118 mL in 1 BOTTLE (10631-206-01)
RIOMET metformin hydrochloride SOLUTION;ORAL 021591 NDA Sun Pharmaceutical Industries, Inc. 10631-206 10631-206-02 473 mL in 1 BOTTLE (10631-206-02)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength500MG/5ML
Approval Date:Sep 11, 2003TE:RLD:Yes

Expired US Patents for NDA 021591

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ranbaxy RIOMET metformin hydrochloride SOLUTION;ORAL 021591-001 Sep 11, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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