Application 213878

Type: ANDA
Sponsor: MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	CABOZANTINIB	CABOZANTINIB	TABLET	40MG	No	No
003	CABOZANTINIB	CABOZANTINIB	TABLET	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A213878-001	CABOZANTINIB S-MALATE	CABOZANTINIB S-MALATE	EQ 20MG BASE	TABLET / ORAL	AB	2026-08-14
A213878-002	CABOZANTINIB S-MALATE	CABOZANTINIB S-MALATE	EQ 40MG BASE	TABLET / ORAL	AB	2026-08-14
A213878-003	CABOZANTINIB S-MALATE	CABOZANTINIB S-MALATE	EQ 60MG BASE	TABLET / ORAL	AB	2026-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A213878-001	AB
A213878-002	AB
A213878-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213878-001	CABOZANTINIB S-MALATE	EQ 20MG BASE	TABLET / ORAL	AB	2026-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213878-002	CABOZANTINIB S-MALATE	EQ 40MG BASE	TABLET / ORAL	AB	2026-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213878-003	CABOZANTINIB S-MALATE	EQ 60MG BASE	TABLET / ORAL	AB	2026-08-14	`84e616aacf4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213878-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213878-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213878-003	AB	1	`84e616aacf4f…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CABOMETYX	CABOZANTINIB	Exelixis, Inc.	3850cce2-6137-42e5-a792-d318c4a4b3b5	2025-10-19	Warnings, Adverse reactions	Name fallback generic name: CABOZANTINIB
COMETRIQ	CABOZANTINIB	Exelixis, Inc.	1a0c3bea-c87b-4d25-bb44-5f0174da6b34	2025-10-18	Warnings, Adverse reactions	Name fallback generic name: CABOZANTINIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.