Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213218
Company: SARFE PHARMS

Products on NDA 213218

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOAANZ	TORSEMIDE	20MG	TABLET;ORAL	Discontinued	None	Yes	No
SOAANZ	TORSEMIDE	60MG	TABLET;ORAL	Discontinued	None	Yes	No
SOAANZ	TORSEMIDE	40MG	TABLET;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213218

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2021	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213218s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213218Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/213218Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-1	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213218s001lbl.pdf

Labels for NDA 213218

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2021	SUPPL-1	Manufacturing (CMC)-New Strength	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213218s001lbl.pdf
06/14/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213218s000lbl.pdf