Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206197
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS 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
06/09/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206197Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/09/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206197Orig1s000lbl.pdf

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS; EQ 150MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EMEND FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription Yes AP 022023 MERCK AND CO INC
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 205020 APOTEX
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 211860 BAXTER HLTHCARE CORP
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 212309 BE PHARMS
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 206197 FRESENIUS KABI USA
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 210689 LUPIN LTD
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 209965 MSN LABS PVT LTD
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 204015 MYLAN LABS LTD
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 211624 SUNGEN PHARMA

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