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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218231

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NDA 218231 describes PAZOPANIB HYDROCHLORIDE, which is a drug marketed by Apotex, Eugia Pharma, Novugen, Sun Pharm, Teva Pharms Inc, and Torrent, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the PAZOPANIB HYDROCHLORIDE profile page.

The generic ingredient in PAZOPANIB HYDROCHLORIDE is pazopanib hydrochloride. There are five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the pazopanib hydrochloride profile page.

Summary for 218231

Tradename:	PAZOPANIB HYDROCHLORIDE
Applicant:	Novugen
Ingredient:	pazopanib hydrochloride
Patents:	0

Pharmacology for NDA: 218231

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 218231

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PAZOPANIB HYDROCHLORIDE	pazopanib hydrochloride	TABLET;ORAL	218231	ANDA	Novugen Pharma (USA) LLC.	82293-022	82293-022-10	120 TABLET, FILM COATED in 1 BOTTLE (82293-022-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Apr 23, 2024	TE:	AB	RLD:	No

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