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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018415
Company: ESJAY PHARMA

Products on NDA 018415

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	AB	No	No
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	AB	No	No
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/1982	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2022	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018415s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018415Orig1s028ltr.pdf
10/01/2014	SUPPL-26	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018415Orig1s026ltr.pdf
06/08/1999	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
11/14/1995	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/01/1993	SUPPL-22	Labeling		Label is not available on this site.
06/30/1993	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
03/26/1992	SUPPL-20	Labeling		Label is not available on this site.
08/09/1989	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/09/1989	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
11/04/1988	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
11/04/1988	SUPPL-15	Labeling		Label is not available on this site.
11/04/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
11/04/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/04/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/06/1986	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/06/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/17/1987	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018415

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2022	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018415s028lbl.pdf

Therapeutic Equivalents for NDA 018415

FUROSEMIDE

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	218831	AUROBINDO PHARMA LTD
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	018569	EPIC PHARMA LLC
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	018415	ESJAY PHARMA
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	216629	GRAVITI PHARMS
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	018823	HIKMA
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	078010	IPCA LABS LTD
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	077293	LEADING
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	218831	AUROBINDO PHARMA LTD
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	018569	EPIC PHARMA LLC
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	018415	ESJAY PHARMA
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	216629	GRAVITI PHARMS
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	018823	HIKMA
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	078010	IPCA LABS LTD
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	077293	LEADING
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC

TABLET;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	218831	AUROBINDO PHARMA LTD
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	018569	EPIC PHARMA LLC
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	018415	ESJAY PHARMA
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	216629	GRAVITI PHARMS
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	070086	HIKMA
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	078010	IPCA LABS LTD
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	077293	LEADING
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC

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