Application 207427

Type: ANDA
Sponsor: BEXIMCO PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	750MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207427-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-12-13
A207427-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207427-001	AB1
A207427-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207427-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-12-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207427-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-12-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207427-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207427-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207427-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207427-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207427-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207427-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207427-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207427-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207427-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207427-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207427-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207427-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207427-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207427-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207427-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207427-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207427-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207427-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207427-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207427-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207427-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207427-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207427-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207427-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207427-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207427-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207427-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207427-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207427-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207427-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207427-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207427-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207427-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207427-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207427-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207427-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207427-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207427-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207427-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207427-002	AB	1	`bb7c543d1eb4…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	17050df5-9e95-4e1b-ac75-34add289b139	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427 ndc (product): 72789-105 ndc (product): 72789-106
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	UNICHEM PHARMACEUTICALS (USA), INC.	93c8deae-3103-4cbf-a5d1-fe0d37e76df8	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427 ndc (product): 76385-128 ndc (product): 76385-129
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	AvKARE	1aa40000-877f-8ea4-e063-6394a90a0e31	2025-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	27d6fdbc-27a8-c599-e063-6394a90a2233	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	242538d7-fb79-4df6-e063-6394a90a5b96	2024-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1ebaab3a-3d62-4c36-853f-c8784993eafb	2023-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427 ndc (product): 71610-666
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c789254c-be70-4d25-8c6c-b284b01eb513	2022-02-22	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427 ndc (product): 71610-587
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5e5fb10b-b874-43c9-9424-9080b9e866c8	2022-02-22	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 207427 application number: ANDA207427 ndc (product): 71610-554

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71610-554	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-554	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-554	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-587	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-587	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-666	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72789-105	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-105	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-105	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-105	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-105	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-106	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-106	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-106	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-106	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-106	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
76385-128	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-128	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-128	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-128	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-128	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-129	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-129	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-129	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-129	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current
76385-129	Metformin hydrochloride	Metformin hydrochloride	Bayshore Pharmaceuticals LLC	ANDA	Current