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 42.

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202270-001	JANUMET XR	500MG;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	JANUMET XR	1GM;EQ 50MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	JANUMET XR	1GM;EQ 100MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-02-02	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202270-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202270-003	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 495 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-08-18 06:07:40	2026-07	N202270-001	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-001	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-002	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	7326708	2026-11-24	U-1227	Drug substance, Drug product	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202270-003	7326708*PED	2027-05-24		Pediatric extension	`caaa826d4ba7…`
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…`

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#

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
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