Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217713
Company: APOTEX

Products on ANDA 217713

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217713

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/19/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217713Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217713

PAZOPANIB HYDROCHLORIDE

TABLET;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	217713	APOTEX
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	219034	EUGIA PHARMA
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	218231	NOVUGEN
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	215837	SUN PHARM
PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	217517	TEVA PHARMS INC
VOTRIENT	PAZOPANIB HYDROCHLORIDE	EQ 200MG BASE	TABLET;ORAL	Prescription	Yes	AB	022465	NOVARTIS