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Details for New Drug Application (NDA): 021591

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NDA 021591 describes RIOMET, which is a drug marketed by Sun Pharm Inds Ltd 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 profile page.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-seven drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for NDA: 021591

Tradename:
RIOMET
Applicant:
Sun Pharm Inds Ltd
Ingredient:
metformin hydrochloride
Patents:1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 021591

Ingredient-typeBiguanides

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 Ranbaxy Laboratories Inc. 10631-206 10631-206-01 118 mL in 1 BOTTLE (10631-206-01)
RIOMET
metformin hydrochloride
SOLUTION;ORAL 021591 NDA Ranbaxy Laboratories Inc. 10631-206 10631-206-02 473 mL in 1 BOTTLE (10631-206-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/5ML
Approval Date:Sep 11, 2003TE:RLD:Yes
Patent:6,890,957Patent Expiration:Sep 14, 2023Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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