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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 079148

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Summary for 079148
Tradename:METFORMIN HYDROCHLORIDE
Applicant:Indicus Pharma
Ingredient:metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079148
Medical Subject Heading (MeSH) Categories for 079148
Suppliers and Packaging for NDA: 079148
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 079148 ANDA INDICUS PHARMA LLC 24724-014 24724-014-01 100 TABLET, FILM COATED in 1 BOTTLE (24724-014-01)
METFORMIN HYDROCHLORIDE metformin hydrochloride TABLET;ORAL 079148 ANDA INDICUS PHARMA LLC 24724-014 24724-014-50 500 TABLET, FILM COATED in 1 BOTTLE (24724-014-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Nov 25, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Nov 25, 2008TE:ABRLD:No

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