Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070655
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 10MG/ML SOLUTION;ORAL Prescription AA 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
10/01/1987 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
01/08/2010 SUPPL-16 Labeling-Container/Carton Labels

Label is not available on this site.

11/16/2009 SUPPL-15 Labeling-Medication Guide

Label is not available on this site.

02/13/2004 SUPPL-12 Labeling

Label is not available on this site.

03/03/1997 SUPPL-10 Labeling

Label is not available on this site.

03/15/1996 SUPPL-9 Labeling

Label is not available on this site.

08/04/1994 SUPPL-8 Labeling

Label is not available on this site.

04/06/1992 SUPPL-7 Labeling

Label is not available on this site.

01/16/1992 SUPPL-6 Labeling

Label is not available on this site.

06/05/1991 SUPPL-5 Labeling

Label is not available on this site.

10/24/1990 SUPPL-4 Labeling

Label is not available on this site.

04/03/1990 SUPPL-3 Labeling

Label is not available on this site.

04/03/1990 SUPPL-2 Labeling

Label is not available on this site.

01/25/1989 SUPPL-1 Labeling

Label is not available on this site.

FUROSEMIDE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FUROSEMIDE FUROSEMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 070434 WEST-WARD PHARMS INT
FUROSEMIDE FUROSEMIDE 10MG/ML SOLUTION;ORAL Prescription No AA 070655 WOCKHARDT BIO AG

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