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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078010
Company: IPCA LABS LTD

Products on ANDA 078010

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 ANDA 078010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2006	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
05/28/2020	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
05/28/2020	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/30/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/27/2011	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/09/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078010

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	018569	EPIC PHARMA LLC
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	018487	MYLAN
FUROSEMIDE	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC
LASIX	FUROSEMIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	016273	VALIDUS PHARMS

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	018569	EPIC PHARMA LLC
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	018487	MYLAN
FUROSEMIDE	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC
LASIX	FUROSEMIDE	40MG	TABLET;ORAL	Prescription	Yes	AB	016273	VALIDUS PHARMS

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	018569	EPIC PHARMA LLC
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	070082	MYLAN
FUROSEMIDE	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	No	AB	076796	PRINSTON INC
LASIX	FUROSEMIDE	80MG	TABLET;ORAL	Prescription	Yes	AB	016273	VALIDUS PHARMS

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