Application 208880

Type: ANDA
Sponsor: PRINSTON INC

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 43.

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
A208880-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-09-10
A208880-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208880-001	AB1
A208880-002	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 · 86 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	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208880-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2018-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208880-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-09-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208880-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208880-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208880-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208880-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208880-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208880-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208880-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208880-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208880-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208880-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208880-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208880-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208880-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208880-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208880-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208880-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208880-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208880-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208880-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208880-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208880-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208880-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208880-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208880-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208880-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208880-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208880-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208880-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208880-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208880-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208880-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208880-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208880-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208880-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208880-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208880-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208880-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208880-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208880-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208880-002	AB	1	`74a2ff9319b5…`

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 6 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	3ba957ea-28ed-4a61-a318-98064ea4944d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f31c08fc-cda1-349c-e053-2a95a90aba15	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	dae7b1c1-7ff1-883c-e053-2a95a90a1a2b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a27d7a-ade4-421f-e053-2a95a90a01a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	07d8a69f-30d9-7511-e063-6394a90a95ca	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	0178b9dd-bafa-9e81-e063-6294a90a88b0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f5ef117c-27ff-c21e-e053-2995a90ae145	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	db113f46-6fac-9005-e053-2995a90a017a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Micro Labs Limited	cc070735-5e8d-4bb3-9caa-e84d29bb8943	2025-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b63bfafa-db4c-4fb8-84cd-ff73a5e7d320	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METFORMIN HYDROCHLORIDE generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE TABLET	Quallent Pharmaceuticals Health LLC	f39ee08d-73db-71b9-e053-2995a90a877c	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	37ff1b8e-a434-41c0-82e1-4583842921a5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin hydrochloride ER	METFORMIN HYDROCHLORIDE	AvKARE	1aa40000-877f-8ea4-e063-6394a90a0e31	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mullan Pharmaceutical Inc.	082b4de9-e452-fe71-e063-6394a90ac863	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	0230a3c3-34cf-478b-88c3-4d96e5300018	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metformin Hydrochloride generic name: METFORMIN HYDROCHLORIDE
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	c72cfd1a-dce9-43a3-88e2-3cf1d9078b52	2025-10-15	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.