Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018667
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription AP 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
05/28/1982 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
09/22/2016 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018667s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018667Orig1s036ltr.pdf
05/10/2012 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

10/25/2002 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/07/2000 SUPPL-16 Labeling

Label is not available on this site.

01/07/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

05/12/1997 SUPPL-14 Labeling

Label is not available on this site.

10/03/1996 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/27/1994 SUPPL-9 Labeling

Label is not available on this site.

03/09/1993 SUPPL-8 Labeling

Label is not available on this site.

07/09/1992 SUPPL-7 Labeling

Label is not available on this site.

06/16/1988 SUPPL-6 Labeling

Label is not available on this site.

01/20/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/20/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/20/1988 SUPPL-1 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
09/22/2016 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018667s036lbl.pdf

FUROSEMIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207552 AMNEAL PHARMS CO
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 212174 AUROBINDO PHARMA LTD
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 202747 BAXTER HLTHCARE CORP
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 203428 EMCURE PHARMS LTD
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 018902 FRESENIUS KABI USA
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 018667 HOSPIRA
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 075241 HOSPIRA
FUROSEMIDE FUROSEMIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 077941 WOCKHARDT

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