Application 219922

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	TABLET;ORAL	EQ 400MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A219922-001	PAZOPANIB HYDROCHLORIDE	PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL			2025-09-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
A219922-001	CGT	2026-05-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A219922-001	PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	2025-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219922-001	PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	2025-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219922-001	PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	2025-09-04	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219922-001	PAZOPANIB HYDROCHLORIDE	EQ 400MG BASE	TABLET / ORAL	2025-09-04	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	A219922-001	CGT	2026-05-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A219922-001	CGT	2026-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219922-001	CGT	2026-05-06	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219922-001	CGT	2026-05-06	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pazopanib	PAZOPANIB HYDROCHLORIDE	Torrent Pharmaceuticals Limited	7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219922 application number: ANDA219922