Application 090295

Type: ANDA
Sponsor: MARKSANS PHARMA

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
A090295-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2016-04-29
A090295-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2016-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090295-001	AB1
A090295-002	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	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090295-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2016-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090295-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2016-04-29	`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	A090295-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090295-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090295-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090295-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090295-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090295-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090295-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090295-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090295-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090295-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090295-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090295-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090295-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090295-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090295-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090295-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090295-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090295-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090295-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090295-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090295-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090295-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090295-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090295-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090295-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090295-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090295-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090295-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090295-002	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	14f3091c-f243-4364-b433-727c7d4ef8d5	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 72789-009
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	MARKSANS PHARMA LIMITED	d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 25000-102 ndc (product): 25000-101
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d1d7204a-7e8a-4f76-bf9f-3e798c2632ba	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 43063-902
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	4e5a19c6-6ac6-ffc0-e063-6394a90a9827	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	1d8b8970-c2a1-4780-be87-ab8ccfd401fa	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 49483-623 ndc (product): 49483-624
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	d7c1ff9e-4faa-4f65-9c87-e8108499791f	2025-03-28	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 71335-0889
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	3e55944a-ed5b-4892-804f-abbe15b0d70c	2025-03-28	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 71335-0293
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Proficient Rx LP	f1530d4f-21d9-4a4f-a814-07b180828ecd	2025-02-01	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 72189-064
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4a53ea53-3052-614b-e054-00144ff8d46c	2024-07-19	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 68071-3111
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	0b843f12-a654-4751-be1f-55e6fce163c9	2021-12-08	Warnings	Exact identifier application applno (ANDA): 090295 application number: ANDA090295 ndc (product): 71610-454

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 52 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25000-101	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-101	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-102	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
25000-102	Metformin Hydrochloride	Metformin Hydrochloride	MARKSANS PHARMA LIMITED	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-902	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
49483-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	ANDA	Current
49483-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	ANDA	Current
49483-624	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	ANDA	Current
49483-624	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	TIME CAP LABORATORIES, INC	ANDA	Current
60760-623	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	St. Marys Medical Park Pharmacy	ANDA	Current
61919-922	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	DIRECT RX	ANDA	Current
61919-922	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	DIRECT RX	ANDA	Current
68071-3111	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3111	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-6932	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6932	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6932	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6932	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7337	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7337	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8225	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Preferred PHarmaceuticals Inc.	ANDA	Current
70518-0899	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-0899	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2480	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70934-309	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-334	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0293	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0293	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0889	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0889	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-0889	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1310	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current
71610-454	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-454	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-064	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	metformin hydrochloride	direct rx	ANDA	Current
72189-064	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	metformin hydrochloride	direct rx	ANDA	Current
72189-064	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	metformin hydrochloride	direct rx	ANDA	Current
72189-064	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	metformin hydrochloride	direct rx	ANDA	Current
72789-009	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-009	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-009	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-009	METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ANDA	Current