Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070433
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 40MG/5ML SOLUTION;ORAL Prescription None No No
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
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.

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