Application 202270

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 50MG BASE	Yes	No
002	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 50MG BASE	Yes	No
003	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 100MG BASE	Yes	Yes

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

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	RLD / RS	Approval date
N202270-001	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02
N202270-002	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02
N202270-003	JANUMET XR	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-02-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N202270-001	AB
N202270-002	AB
N202270-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status
N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-001	7326708*PED	2027-05-24		Pediatric extension
N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-002	7326708*PED	2027-05-24		Pediatric extension
N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product
N202270-003	7326708*PED	2027-05-24		Pediatric extension

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 4 · 123 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	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2012-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2012-02-02	`8072bd15b7f6…`

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	2026-06	N202270-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC	2026-06	N202270-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC	2026-06	N202270-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 489 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 213 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-001	PED	2024-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	M-187	2023-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202270-002	PED	2024-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-001	PED	2024-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	M-187	2023-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202270-002	PED	2024-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-001	PED	2024-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	M-187	2023-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202270-002	PED	2024-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-001	PED	2024-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	M-187	2023-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202270-002	PED	2024-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202270-001	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-001	PED	2024-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	M-187	2023-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202270-002	PED	2024-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-001	PED	2024-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	M-187	2023-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202270-002	PED	2024-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-001	PED	2024-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	M-187	2023-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202270-002	PED	2024-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-001	PED	2024-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	M-187	2023-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202270-002	PED	2024-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202270-001	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-001	PED	2024-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-002	M-187	2023-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202270-002	PED	2024-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	M-244	2022-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	PED	2023-02-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	M-187	2023-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202270-001	PED	2024-06-04	`5c6f7cd8ea54…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
JANUMET XR	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	Merck Sharp & Dohme LLC	64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b50	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202270 application number: NDA202270 ndc (product): 0006-0080 ndc (product): 0006-0078 ndc (product): 0006-0081
JANUMET XR	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	90c0244b-afb3-4e69-b79f-486d002ca432	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202270 application number: NDA202270

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0078	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0080	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme LLC	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
0006-0081	JANUMET	sitagliptin and metformin hydrochloride	Merck Sharp & Dohme Corp.	NDA	Current
50090-4411	JANUMET	sitagliptin and metformin hydrochloride	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71438	SUPPL	2022-06-24
71437	SUPPL	2022-06-24
71427	SUPPL	2022-06-22
69273	SUPPL	2021-11-08
69262	SUPPL	2021-11-05
65546	SUPPL	2020-12-09
65522	SUPPL	2020-12-08
65501	SUPPL	2020-12-04
59690	SUPPL	2019-08-13
59682	SUPPL	2019-08-13
59282	SUPPL	2019-07-09
59209	SUPPL	2019-07-02
52635	SUPPL	2018-02-14
52561	SUPPL	2018-02-12
52556	SUPPL	2018-02-12
49407	SUPPL	2017-08-15
49352	SUPPL	2017-08-14
46933	SUPPL	2017-01-24
46932	SUPPL	2017-01-24
46925	SUPPL	2017-01-18
46924	SUPPL	2017-01-18
19309	SUPPL	2015-09-04
32222	SUPPL	2015-09-01
40155	SUPPL	2015-05-04
10010	SUPPL	2015-04-29
40154	SUPPL	2014-02-13
32221	SUPPL	2014-02-13
43392	ORIG	2013-09-03
24412	ORIG	2013-09-03
10009	SUPPL	2013-02-13
40153	SUPPL	2013-02-11
19308	SUPPL	2012-10-22
10008	SUPPL	2012-10-22
19307	ORIG	2012-02-06
10007	ORIG	2012-02-06