Application 205981

Type: ANDA
Sponsor: MYLAN

Application Products#

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

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	Approval date
A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31
A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31
A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205981-001	AB
A205981-002	AB
A205981-003	AB

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 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-002	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 2.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-003	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	1GM;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205981-001	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	500MG;EQ 5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2023-07-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205981-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205981-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205981-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205981-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205981-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205981-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205981-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205981-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205981-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205981-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205981-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205981-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205981-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205981-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205981-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205981-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205981-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205981-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205981-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205981-001	AB	1	`8072bd15b7f6…`

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
Saxagliptin and Metformin	SAXAGLIPTIN AND METFORMIN	Mylan Pharmaceuticals Inc.	cbf8677c-cafe-48bc-8844-0cc6547886bd	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205981 application number: ANDA205981

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75167	ORIG	2023-08-21