Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070433
Company: HIKMA

Products on ANDA 070433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FUROSEMIDE	FUROSEMIDE	40MG/5ML	SOLUTION;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1987	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-35	Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
05/11/2012	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
01/26/2011	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
05/04/2009	SUPPL-27	Labeling		Label is not available on this site.
03/28/2007	SUPPL-26	Labeling		Label is not available on this site.
05/23/2002	SUPPL-22	Manufacturing (CMC)-Facility		Label is not available on this site.
09/22/2000	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/22/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
10/08/1998	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/21/1997	SUPPL-15	Labeling		Label is not available on this site.
04/21/1997	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/21/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/21/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/21/1997	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/24/1994	SUPPL-10	Labeling		Label is not available on this site.
08/28/1992	SUPPL-9	Labeling		Label is not available on this site.
12/18/1990	SUPPL-8	Labeling		Label is not available on this site.
12/28/1989	SUPPL-7	Labeling		Label is not available on this site.
11/07/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/07/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/19/1989	SUPPL-2	Labeling		Label is not available on this site.
07/13/1988	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.