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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 211309

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NDA 211309 describes METFORMIN HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, Micro Labs, Mpp Pharma, Mylan Pharms Inc, Nostrum Pharms Llc, Novast Labs, Pharmobedient, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Regcon Holdings, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Aarxion Anda Hlding, Alkem, Anda Repository, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, and Zydus Pharms Usa, and is included in one hundred and four NDAs. It is available from eighty-four suppliers. Additional details are available on the METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for 211309

Tradename:	METFORMIN HYDROCHLORIDE
Applicant:	Saptalis Pharms
Ingredient:	metformin hydrochloride
Patents:	0

Pharmacology for NDA: 211309

Medical Subject Heading (MeSH) Categories for 211309

Hypoglycemic Agents

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:	RX	Dosage:	SOLUTION;ORAL			Strength	500MG/5ML
Approval Date:	Mar 3, 2020	TE:	AB	RLD:	No

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