Application 210449

Type: ANDA
Sponsor: APOTEX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CANAGLIFLOZIN	CANAGLIFLOZIN	TABLET;ORAL	100MG	No	No
002	CANAGLIFLOZIN	CANAGLIFLOZIN	TABLET;ORAL	300MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210449-001	CANAGLIFLOZIN	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB		2026-04-14
A210449-002	CANAGLIFLOZIN	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB		2026-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210449-001	AB
A210449-002	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	A210449-001	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB	2026-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210449-002	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB	2026-04-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210449-001	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB	2026-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210449-002	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB	2026-04-14	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210449-001	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB	2026-04-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210449-002	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB	2026-04-14	`a50c72e98297…`

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	A210449-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210449-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210449-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210449-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210449-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210449-002	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
INVOKANA	CANAGLIFLOZIN	Janssen Pharmaceuticals, Inc.	b9057d3b-b104-4f09-8a61-c61ef9d4a3f3	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: CANAGLIFLOZIN
INVOKANA	CANAGLIFLOZIN	Cardinal Health 107, LLC	5f76e16f-0c24-454a-81af-4080b312c940	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: CANAGLIFLOZIN
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	9679460c-55f7-4826-b55c-fe116f020358	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: CANAGLIFLOZIN
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	8d5f892b-e4f3-4a9e-9a91-95e2fca34144	2023-12-15	Warnings, Adverse reactions	Name fallback generic name: CANAGLIFLOZIN

Reported adverse events (FAERS/openFDA)#

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