Application 205879

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	50MG;500MG	Yes	No
002	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	50MG;1GM	Yes	No
003	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG;500MG	Yes	No
004	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	150MG;1GM	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205879-001	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20
N205879-002	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20
N205879-003	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20
N205879-004	INVOKAMET XR	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20

Orange Book patents#

Current patent rows page 1 of 1 · 40 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205879-001	7943788	2027-07-14		Drug substance, Drug product	2016-10-14
N205879-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14
N205879-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14
N205879-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14
N205879-001	7943788*PED	2028-01-14		Pediatric extension
N205879-001	8513202*PED	2028-06-03		Pediatric extension
N205879-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14
N205879-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14
N205879-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14
N205879-001	7943582*PED	2029-08-26		Pediatric extension
N205879-002	7943788	2027-07-14		Drug substance, Drug product	2016-10-14
N205879-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14
N205879-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14
N205879-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14
N205879-002	7943788*PED	2028-01-14		Pediatric extension
N205879-002	8513202*PED	2028-06-03		Pediatric extension
N205879-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14
N205879-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14
N205879-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14
N205879-002	7943582*PED	2029-08-26		Pediatric extension
N205879-003	7943788	2027-07-14		Drug substance, Drug product	2016-10-14
N205879-003	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14
N205879-003	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14
N205879-003	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14
N205879-003	7943788*PED	2028-01-14		Pediatric extension
N205879-003	8513202*PED	2028-06-03		Pediatric extension
N205879-003	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14
N205879-003	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14
N205879-003	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14
N205879-003	7943582*PED	2029-08-26		Pediatric extension
N205879-004	7943788	2027-07-14		Drug substance, Drug product	2016-10-14
N205879-004	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14
N205879-004	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14
N205879-004	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14
N205879-004	7943788*PED	2028-01-14		Pediatric extension
N205879-004	8513202*PED	2028-06-03		Pediatric extension
N205879-004	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14
N205879-004	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14
N205879-004	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14
N205879-004	7943582*PED	2029-08-26		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N205879-001	NPP	2027-12-18
N205879-001	PED	2028-06-18
N205879-002	NPP	2027-12-18
N205879-002	PED	2028-06-18
N205879-003	NPP	2027-12-18
N205879-003	PED	2028-06-18
N205879-004	NPP	2027-12-18
N205879-004	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 5 · 164 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	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205879-001	INVOKAMET XR	50MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205879-002	INVOKAMET XR	50MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205879-003	INVOKAMET XR	150MG;500MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2016-09-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205879-004	INVOKAMET XR	150MG;1GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2016-09-20	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 46 · 1,830 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	N205879-001	7943788	2027-07-14		Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943788	2027-07-14		Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943788	2027-07-14		Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943788	2027-07-14		Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	8513202	2027-12-03	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	8513202	2027-12-03	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	8513202	2027-12-03	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943788*PED	2028-01-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	8513202*PED	2028-06-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943582	2029-02-26	U-2441	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943582	2029-02-26	U-2632	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943582	2029-02-26	U-493	Drug substance, Drug product	2016-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	7943582*PED	2029-08-26		Pediatric extension		`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 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	N205879-001	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-001	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-002	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-003	PED	2028-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	NPP	2027-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205879-004	PED	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-001	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-001	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-002	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-002	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-003	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-003	PED	2028-06-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-004	NPP	2027-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205879-004	PED	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205879-001	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-001	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-002	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-002	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-003	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-003	PED	2028-06-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-004	NPP	2027-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205879-004	PED	2028-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-001	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-001	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-002	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-002	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-003	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-003	PED	2028-06-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-004	NPP	2027-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205879-004	PED	2028-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-001	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-001	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-002	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-002	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-003	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-003	PED	2028-06-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-004	NPP	2027-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205879-004	PED	2028-06-18	`b8a1b40f171c…`

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
INVOKAMET	CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	6868666b-c25e-40d1-9d1f-306bbe9390c1	2025-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205879 application number: NDA205879 ndc (product): 50458-943 ndc (product): 50458-941 ndc (product): 50458-942 ndc (product): 50458-940

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-940	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-941	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-942	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-943	INVOKAMET XR	canagliflozin and metformin hydrochloride	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80654	SUPPL	2024-12-19
80635	SUPPL	2024-12-19
80634	SUPPL	2024-12-19
79483	SUPPL	2024-08-26
79474	SUPPL	2024-08-26
77272	SUPPL	2024-01-23
77263	SUPPL	2024-01-22
74708	SUPPL	2023-07-07
74701	SUPPL	2023-07-06
72349	SUPPL	2022-10-17
72347	SUPPL	2022-10-17
72333	SUPPL	2022-10-14
64320	SUPPL	2020-08-19
64319	SUPPL	2020-08-19
64307	SUPPL	2020-08-19
61711	SUPPL	2020-01-28
61710	SUPPL	2020-01-28
61704	SUPPL	2020-01-28
61694	SUPPL	2020-01-27
61650	SUPPL	2020-01-27
56212	SUPPL	2018-10-31
56206	SUPPL	2018-10-31
56199	SUPPL	2018-10-30
56174	SUPPL	2018-10-30
50958	SUPPL	2018-01-03
50957	SUPPL	2018-01-03
50516	ORIG	2017-11-28
49483	SUPPL	2017-08-21
49359	SUPPL	2017-08-14
49118	SUPPL	2017-07-28
49060	SUPPL	2017-07-25
45410	ORIG	2016-09-29
45409	ORIG	2016-09-29