Application 204042

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N204042-001	INVOKANA	CANAGLIFLOZIN	100MG	TABLET / ORAL	AB	RLD	2013-03-29
N204042-002	INVOKANA	CANAGLIFLOZIN	300MG	TABLET / ORAL	AB	RLD, RS	2013-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204042-001	AB
N204042-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16
N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16
N204042-001	7943788*PED	2028-01-14		Pediatric extension
N204042-001	8513202*PED	2028-06-03		Pediatric extension
N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16
N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16
N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16
N204042-001	7943582*PED	2029-08-26		Pediatric extension
N204042-002	7943788	2027-07-14		Drug substance, Drug product
N204042-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16
N204042-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16
N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16
N204042-002	7943788*PED	2028-01-14		Pediatric extension
N204042-002	8513202*PED	2028-06-03		Pediatric extension
N204042-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16
N204042-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16
N204042-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16
N204042-002	7943582*PED	2029-08-26		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204042-001	NPP	2027-12-18
N204042-001	PED	2028-06-18
N204042-002	NPP	2027-12-18
N204042-002	PED	2028-06-18

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204042-001	INVOKANA	100MG	TABLET / ORAL	RLD	2013-03-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	INVOKANA	300MG	TABLET / ORAL	RLD, RS	2013-03-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204042-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204042-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 36 · 1,428 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943788	2027-07-14		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-493		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-2441		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219	2025-04-11	U-2632		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8222219*PED	2025-10-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943788	2027-07-14		Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943788*PED	2028-01-14		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	8513202*PED	2028-06-03		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	7943582*PED	2029-08-26		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-493		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-2632		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219	2025-04-11	U-2441		2013-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8222219*PED	2025-10-11		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	7943788	2027-07-14		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2013-04-16	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204042-001	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-001	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204042-002	PED	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-001	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204042-002	PED	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204042-001	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-001	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204042-002	PED	2028-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-001	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204042-002	PED	2028-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-001	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204042-002	PED	2028-06-18	`b8a1b40f171c…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-001	I-809	2022-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204042-002	I-809	2022-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204042-001	I-809	2022-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204042-002	I-809	2022-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204042-001	I-809	2022-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204042-002	I-809	2022-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-733	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	M-197	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-788	2021-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-001	I-809	2022-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-733	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	M-197	2020-02-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-788	2021-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204042-002	I-809	2022-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204042-001	I-809	2022-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204042-002	I-809	2022-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204042-001	I-788	2021-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-001	I-809	2022-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	I-788	2021-10-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204042-002	I-809	2022-09-27	`782e0a99824c…`

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	Exact identifier application applno (NDA): 204042 application number: NDA204042 ndc (product): 50458-140 ndc (product): 50458-141
INVOKANA	CANAGLIFLOZIN	Cardinal Health 107, LLC	5f76e16f-0c24-454a-81af-4080b312c940	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042 ndc (product): 55154-1425 ndc (product): 55154-1426
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	9679460c-55f7-4826-b55c-fe116f020358	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042 ndc (product): 50090-4364
INVOKANA	CANAGLIFLOZIN	A-S Medication Solutions	8d5f892b-e4f3-4a9e-9a91-95e2fca34144	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204042 application number: NDA204042 ndc (product): 50090-5034

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 41 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4364	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-4364	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-4364	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-4364	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5029	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5029	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5033	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5033	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5033	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5034	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5034	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5034	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50090-5034	INVOKANA	canagliflozin	A-S Medication Solutions	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-140	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-141	INVOKANA	canagliflozin	Janssen Pharmaceuticals, Inc.	NDA	Current
55154-1425	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1425	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1425	INVOKANA	canagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-1425	INVOKANA	canagliflozin	.Cardinal Health	NDA	Current
55154-1425	INVOKANA	canagliflozin	.Cardinal Health	NDA	Current
55154-1425	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1425	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	Cardinal Health 107, LLC	NDA	Current
55154-1426	INVOKANA	canagliflozin	.Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	.Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	Cardinal Health	NDA	Current
55154-1426	INVOKANA	canagliflozin	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80653	SUPPL	2024-12-19
80631	SUPPL	2024-12-19
80630	SUPPL	2024-12-19
79481	SUPPL	2024-08-26
79480	SUPPL	2024-08-26
79470	SUPPL	2024-08-26
79469	SUPPL	2024-08-26
74709	SUPPL	2023-07-07
74697	SUPPL	2023-07-06
72362	SUPPL	2022-10-17
72361	SUPPL	2022-10-17
72331	SUPPL	2022-10-14
68764	SUPPL	2021-09-24
64316	SUPPL	2020-08-19
64315	SUPPL	2020-08-19
64302	SUPPL	2020-08-19
62296	SUPPL	2020-03-24
61692	SUPPL	2020-01-27
61654	SUPPL	2020-01-27
61648	SUPPL	2020-01-27
60529	SUPPL	2019-10-10
60518	SUPPL	2019-10-10
60165	SUPPL	2019-09-30
60160	SUPPL	2019-09-30
56213	SUPPL	2018-10-31
56204	SUPPL	2018-10-31
56192	SUPPL	2018-10-30
56172	SUPPL	2018-10-30
52736	SUPPL	2018-02-27
49116	SUPPL	2017-07-28
49064	SUPPL	2017-07-25
47085	SUPPL	2017-02-01
47084	SUPPL	2017-02-01
45094	SUPPL	2016-08-22
45142	SUPPL	2016-08-17
32496	SUPPL	2016-05-24
10288	SUPPL	2016-05-24
40349	SUPPL	2016-05-23
19518	SUPPL	2016-05-23
40348	SUPPL	2016-03-30
32494	SUPPL	2016-03-30
32495	SUPPL	2015-12-08
19517	SUPPL	2015-12-08
19516	SUPPL	2015-09-11
40347	SUPPL	2015-03-05
10287	SUPPL	2015-03-04
10286	SUPPL	2014-05-20
40346	SUPPL	2014-05-19
43454	ORIG	2013-05-10
60772	ORIG	2013-04-01
40345	ORIG	2013-04-01
32493	ORIG	2013-04-01