Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204015
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 115MG BASE/VIAL POWDER;INTRAVENOUS Discontinued None No No
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
09/05/2019 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204015Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/17/2020 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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 204025 ACCORD HLTHCARE
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 210625 AUROBINDO PHARMA LTD
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 211160 DR REDDYS
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
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 212957 NAVINTA LLC
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 213106 QILU
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 203939 SANDOZ INC
FOSAPREPITANT DIMEGLUMINE FOSAPREPITANT DIMEGLUMINE EQ 150MG BASE/VIAL POWDER;INTRAVENOUS Prescription No AP 211624 SUNGEN PHARMA

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