Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090713
Company: TEVA PHARMS USA

Products on ANDA 090713

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2018	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090713Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 090713

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	202951	AVET LIFESCIENCES
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	209287	CHARTWELL RX
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	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	206416	MYLAN INSTITUTIONAL
PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215861	NANJING KING-FRIEND
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
PALONOSETRON HYDROCHLORIDE	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	090713	TEVA PHARMS USA