Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070086
Company: HIKMA

Products on ANDA 070086

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070086

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/1986	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
11/05/2020	SUPPL-43	Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
05/10/2012	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
01/26/2011	SUPPL-36	Labeling-Package Insert		Label is not available on this site.
05/04/2009	SUPPL-35	Labeling		Label is not available on this site.
03/28/2007	SUPPL-34	Labeling		Label is not available on this site.
05/23/2002	SUPPL-30	Manufacturing (CMC)-Facility		Label is not available on this site.
05/07/2002	SUPPL-29	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/07/2002	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/2002	SUPPL-27	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/30/2001	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
08/30/2001	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
09/10/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
04/22/1997	SUPPL-23	Labeling		Label is not available on this site.
08/28/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/13/1995	SUPPL-21	Labeling		Label is not available on this site.
06/24/1994	SUPPL-20	Labeling		Label is not available on this site.
08/28/1992	SUPPL-19	Labeling		Label is not available on this site.
11/18/1991	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
05/03/1991	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/18/1990	SUPPL-15	Labeling		Label is not available on this site.
03/13/1991	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/28/1989	SUPPL-13	Labeling		Label is not available on this site.
05/03/1991	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/13/1988	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/19/1989	SUPPL-9	Labeling		Label is not available on this site.
05/06/1988	SUPPL-7	Labeling		Label is not available on this site.
07/12/1988	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/13/1991	SUPPL-3	Labeling		Label is not available on this site.
03/13/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/13/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070086

FUROSEMIDE

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