Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018902
Company: FRESENIUS KABI USA
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
05/22/1984 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2016 SUPPL-28 Labeling-Container/Carton Labels Letter (PDF)
Label is not available.

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s028ltr.pdf
03/08/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018902Orig1s027ltr.pdf
07/01/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

03/27/2012 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

01/02/2001 SUPPL-16 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/11/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/15/1997 SUPPL-14 Labeling

Label is not available on this site.

08/08/1997 SUPPL-13 Labeling

Label is not available on this site.

04/22/1997 SUPPL-12 Labeling

Label is not available on this site.

08/10/1995 SUPPL-11 Labeling

Label is not available on this site.

08/10/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/16/1990 SUPPL-8 Labeling

Label is not available on this site.

04/18/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-6 Labeling

Label is not available on this site.

08/10/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/05/1985 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
03/08/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018902s027lbl.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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