Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070082
Company: MYLAN

Products on ANDA 070082

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 070082

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1986	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
08/01/2016	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
08/01/2016	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/04/2008	SUPPL-22	Labeling		Label is not available on this site.
10/22/2001	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
10/22/2001	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
12/07/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/06/1997	SUPPL-13	Labeling		Label is not available on this site.
04/24/1996	SUPPL-12	Labeling		Label is not available on this site.
01/07/1994	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/15/1993	SUPPL-10	Labeling		Label is not available on this site.
04/13/1993	SUPPL-8	Labeling		Label is not available on this site.
05/06/1992	SUPPL-7	Labeling		Label is not available on this site.
03/18/1992	SUPPL-6	Labeling		Label is not available on this site.
12/27/1990	SUPPL-5	Labeling		Label is not available on this site.
05/03/1990	SUPPL-4	Labeling		Label is not available on this site.
01/31/1990	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/16/1990	SUPPL-2	Labeling		Label is not available on this site.
06/10/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070082

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