An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217239
Company: MICRO LABS

Products on ANDA 217239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217239

TORSEMIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076894	COREPHARMA
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	217239	MICRO LABS
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA INTL
TORSEMIDE	TORSEMIDE	5MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA INTL

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076894	COREPHARMA
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	217239	MICRO LABS
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA INTL
TORSEMIDE	TORSEMIDE	10MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA INTL

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	078249	AUROBINDO PHARMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076894	COREPHARMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	079234	HETERO LABS LTD III
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076943	HIKMA
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	217239	MICRO LABS
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076346	PLIVA PHARM IND
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076226	STRIDES PHARMA INTL
TORSEMIDE	TORSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	090613	STRIDES PHARMA INTL

Top