Soaanz

NDA 213218, held by Sarfe Pharms. Torsemide.

As of Nov 14, 2026, NDA 213218 (Soaanz), held by Sarfe Pharms, was first approved by FDA on Jun 14, 2021, with 1 approved supplement and 1 published complete response letter.

First approved: Jun 14, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 1

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 14, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jan 10, 2020	NDA 213218Facility Inspections	Approved

Products

3 strengths and forms


Soaanz20MG · tablet;oral	Torsemide	DiscontinuedReference drug
Soaanz60MG · tablet;oral	Torsemide	DiscontinuedReference drug
Soaanz40MG · tablet;oral	Torsemide	RxReference drug

All 2 submissions, including labeling and manufacturing supplements


Nov 17, 2021	Supplement 1Manufacturing	Approved	Label
Jun 14, 2021	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 213218
Drugs@FDA: Overview at FDA
Company: SARFE Pharms

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters