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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201533
Company: DR REDDYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/21/2016 ORIG-1 Approval Not Applicable Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201533Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201533s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2019 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 206916 BAXTER HLTHCARE CORP
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
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 202951 EMCURE PHARMS LTD
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204702 EUGIA PHARMA
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
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 208789 INGENUS PHARMS LLC
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 HAINAN
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 204289 SAGENT PHARMS INC
PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 205870 SAGENT PHARMS INC
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
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