Application 200678

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	Yes	No
002	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	Yes	Yes
003	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	Yes	No

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	RLD / RS	Approval date
N200678-001	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05
N200678-002	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05
N200678-003	KOMBIGLYZE XR	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N200678-001	M-14	2027-10-11
N200678-002	M-14	2027-10-11
N200678-003	M-14	2027-10-11

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200678-002	KOMBIGLYZE XR	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200678-003	KOMBIGLYZE XR	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200678-001	KOMBIGLYZE XR	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	RLD	2010-11-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200678-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200678-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200678-003	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 378 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-003	8628799	2025-07-13	Drug product	2017-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200678-003	9339472	2025-07-13	Drug product	2017-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-001	8628799	2025-07-13	Drug product	2014-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-001	9339472	2025-07-13	Drug product	2016-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-002	8628799	2025-07-13	Drug product	2017-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200678-002	9339472	2025-07-13	Drug product	2017-03-22	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N200678-001	M-14	2027-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200678-002	M-14	2027-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200678-003	M-14	2027-10-11	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	N200678-001	M-175	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200678-001	M-198	2020-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200678-002	M-175	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200678-002	M-198	2020-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200678-003	M-175	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200678-003	M-198	2020-02-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N200678-001	M-198	2020-02-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200678-002	M-198	2020-02-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200678-003	M-198	2020-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200678-001	M-198	2020-02-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N200678-002	M-198	2020-02-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N200678-003	M-198	2020-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200678-001	M-175	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200678-001	M-198	2020-02-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200678-002	M-175	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200678-002	M-198	2020-02-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200678-003	M-175	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N200678-003	M-198	2020-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200678-001	M-175	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200678-001	M-198	2020-02-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200678-002	M-175	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200678-002	M-198	2020-02-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200678-003	M-175	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N200678-003	M-198	2020-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200678-001	M-175	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200678-001	M-198	2020-02-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200678-002	M-175	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200678-002	M-198	2020-02-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200678-003	M-175	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N200678-003	M-198	2020-02-27	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200678-001	M-14	2027-10-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200678-002	M-14	2027-10-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N200678-003	M-14	2027-10-11	`a50c72e98297…`

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6125	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6135	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current
0310-6145	KOMBIGLYZE	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79907	SUPPL	2024-10-15
79897	SUPPL	2024-10-15
79896	SUPPL	2024-10-15
59275	SUPPL	2019-07-08
59274	SUPPL	2019-07-08
59214	SUPPL	2019-07-02
56371	SUPPL	2018-11-08
47497	SUPPL	2017-03-08
47360	SUPPL	2017-02-28
46931	SUPPL	2017-01-24
46930	SUPPL	2017-01-24
46921	SUPPL	2017-01-18
46920	SUPPL	2017-01-18
45270	SUPPL	2016-09-13
9844	SUPPL	2016-04-07
18977	SUPPL	2015-09-04
9845	SUPPL	2015-09-01
23474	ORIG	2013-06-12
18976	SUPPL	2013-06-04
32052	SUPPL	2013-05-28
32051	SUPPL	2012-04-05
32050	SUPPL	2012-03-13
32049	SUPPL	2012-03-13
40042	SUPPL	2012-03-09
40041	SUPPL	2012-03-09
9843	SUPPL	2011-11-21
40043	SUPPL	2011-11-16
44825	ORIG	2011-09-16
22835	ORIG	2011-09-16
32048	ORIG	2010-11-12
18975	ORIG	2010-11-12