Application 076863

Type: ANDA
Sponsor: BARR

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076863-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL			2004-10-14

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 · 43 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
2026-09-14 22:38:34	2026-08	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2004-10-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076863-001	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL		2004-10-14	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076863-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076863-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076863-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076863-001	AB	1	`ea99ee380514…`

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 13 of 14 · 261 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Solco Healthcare US, LLC.	1016cad7-2198-483c-893b-e25fd397a226	2022-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d51f3618-4166-4925-8994-968a653ebc46	2022-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	5f243894-bda3-4fa9-97e4-209dcb389dee	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS	ScieGen Pharmaceuticals, Inc.	16dc4008-7b5e-4c6d-9bc8-8db96be911a1	2022-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	738402d6-3700-46b2-a90c-2e8f2c354a39	2022-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	c789254c-be70-4d25-8c6c-b284b01eb513	2022-02-22	Boxed warning, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	5e5fb10b-b874-43c9-9424-9080b9e866c8	2022-02-22	Boxed warning, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0b843f12-a654-4751-be1f-55e6fce163c9	2021-12-08	Warnings	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e298db3-439e-4e91-8f9e-01c3cdc4d552	2021-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2021-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS	ScieGen Pharmaceuticals, Inc.	1452fbb1-e591-4a51-9f83-8a8a6a780b52	2021-06-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	439bb230-94d8-4522-ad79-5cce5fad965b	2021-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	9632456f-57c2-444b-9f43-d9ca862681fe	2021-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	ACI Healthcare USA, Inc.	e18b60f9-721e-4db6-9f61-d3437e18faf2	2020-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Epic Pharma, LLC	8c1848f9-c113-4552-b6ef-715e72630ad9	2019-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	6f6118c1-cecc-4d7b-9965-7b114a1ad56b	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	5c2581e3-2b30-4da5-8bed-228173ca20d2	2019-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Riomet	METFORMIN HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	05d4df4b-dfe8-4828-b423-a3d4f2c4114a	2018-12-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Amneal Pharmaceuticals LLC	c01a79e0-f2b7-4d99-857e-bda7f24fe319	2018-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8971	ORIG	2004-10-18