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Last Updated: September 18, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209882

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Summary for 209882
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Laurus Labs Ltd
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209882
Medical Subject Heading (MeSH) Categories for 209882
Suppliers and Packaging for NDA: 209882
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 209882 ANDA Laurus Labs Limited 42385-902 42385-902-01 100 TABLET, FILM COATED in 1 BOTTLE (42385-902-01)
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 209882 ANDA Laurus Labs Limited 42385-902 42385-902-05 500 TABLET, FILM COATED in 1 BOTTLE (42385-902-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 27, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Aug 27, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Aug 27, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Merck
Mallinckrodt
Boehringer Ingelheim
Express Scripts

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