Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211309
Company: SAPTALIS PHARMS

Products on ANDA 211309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2024	SUPPL-9	Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211309

METFORMIN HYDROCHLORIDE

SOLUTION;ORAL; 500MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION;ORAL	Prescription	No	AB	215008	ANNORA PHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION;ORAL	Prescription	No	AB	219151	BIONPHARMA
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION;ORAL	Prescription	No	AB	211309	SAPTALIS PHARMS
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG/5ML	SOLUTION;ORAL	Prescription	No	AB	212677	VISTAPHARM LLC