Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203428
Company: EMCURE PHARMS LTD
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
08/26/2014 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
03/05/2018 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

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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