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Last Updated: August 13, 2020

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Details for New Drug Application (NDA): 211309

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Summary for 211309
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Saptalis Pharms
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211309
Medical Subject Heading (MeSH) Categories for 211309
Suppliers and Packaging for NDA: 211309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride SOLUTION;ORAL 211309 ANDA MICRO LABS LIMITED 42571-360 42571-360-07 473 mL in 1 BOTTLE (42571-360-07)
METFORMIN HYDROCHLORIDE metformin hydrochloride SOLUTION;ORAL 211309 ANDA MICRO LABS LIMITED 42571-360 42571-360-10 118 mL in 1 BOTTLE (42571-360-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength500MG/5ML
Approval Date:Mar 3, 2020TE:ABRLD:No

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