Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075241
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
05/28/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75241ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/10/2012 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/28/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/75-241_Furosemide_prntlbl.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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