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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018579
Company: AM REGENT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
11/30/1983 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
03/30/2022 SUPPL-33 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018579Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/018579Orig1s033ltr.pdf
06/27/2014 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
08/16/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf
06/27/2002 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/27/2002 SUPPL-22 Labeling

Label is not available on this site.
06/27/2002 SUPPL-21 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
07/15/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.
12/04/2000 SUPPL-19 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
12/04/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
12/04/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
05/21/1997 SUPPL-16 Labeling

Label is not available on this site.
07/08/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
02/28/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
06/07/1993 SUPPL-13 Labeling

Label is not available on this site.
12/29/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
04/14/1992 SUPPL-11 Labeling

Label is not available on this site.
08/22/1991 SUPPL-10 Labeling

Label is not available on this site.
08/15/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
08/15/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/15/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/07/1988 SUPPL-6 Labeling

Label is not available on this site.
02/14/1989 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/30/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018579Orig1s033lbl.pdf
03/30/2022 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/018579Orig1s033lbl.pdf
08/16/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018579s029lbl.pdf
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