Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205648
Company: QILU PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription AP No No
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;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
09/19/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205648Orig1s000TAltr.pdf

PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS; EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021372 HELSINN HLTHCARE
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204702 AUROBINDO PHARMA LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206396 CIPLA
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 201533 DR REDDYS LABS LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206801 FRESENIUS KABI USA
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206802 FRESENIUS KABI USA
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207005 HOSPIRA INC
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206416 MYLAN INSTITUTIONAL
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205648 QILU PHARM CO LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204289 SAGENT PHARMS
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205870 SAGENT PHARMS
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 202521 SANDOZ INC
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090713 TEVA PHARMS USA
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 209287 VIRTUS PHARM

INJECTABLE;INTRAVENOUS; EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALOXI PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021372 HELSINN HLTHCARE
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 201533 DR REDDYS LABS LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 207005 HOSPIRA INC
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205648 QILU PHARM CO LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 090713 TEVA PHARMS USA

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