Application 090564

Type: ANDA
Sponsor: GRANULES INDIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	Yes

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

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	RLD / RS	Approval date
A090564-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22
A090564-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22
A090564-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090564-001	AB
A090564-002	AB
A090564-003	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB		2010-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	RS	2010-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB		2010-04-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A090564-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090564-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090564-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090564-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090564-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090564-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090564-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090564-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090564-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090564-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090564-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090564-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090564-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090564-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090564-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090564-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090564-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090564-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090564-001	AB	1	`301d65b070ca…`

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	1c046303-993c-4111-ac9a-40a0d97ca6a2	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	3c607f04-d36f-4cf8-9cc9-7f2af08b4098	2024-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	7cc82387-8bb0-4bee-9967-cb13eab1d801	2024-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d0bc43a4-301f-4002-9b58-bd81dddf2790	2023-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a4679179-af2d-4c84-a1c8-ab0870a4585d	2023-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	A-S Medication Solutions	74f18a3e-0f5c-4172-b499-14f229b431c4	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 50090-4891
Metformin HCl	METFORMIN HCL	Bryant Ranch Prepack	4bdd2faa-2125-4139-b958-196393e31b7e	2023-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	A-S Medication Solutions	4e345b8c-57ab-4f09-9cbe-1d255e9354ba	2023-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 50090-3064
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	34aa1761-d16f-4bfc-b7fa-bf1b0387e8a3	2022-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Proficient Rx LP	53361a39-cb69-483b-a4be-3a4753bf1ba6	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d51f3618-4166-4925-8994-968a653ebc46	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	5f243894-bda3-4fa9-97e4-209dcb389dee	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Bryant Ranch Prepack	1f8833f9-1232-4aa7-a0d4-04a9f87dc2f0	2021-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Epic Pharma, LLC	8c1848f9-c113-4552-b6ef-715e72630ad9	2019-11-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 42806-314 ndc (product): 42806-313 ndc (product): 42806-315
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Metcure Pharmaceuticals, Inc.	5df6adc9-79fd-66ef-e053-2991aa0a75ce	2018-01-22	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Ascend Laboratories, LLC	2d98aea3-35ba-447a-b88f-a5a20b612b2f	2017-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 5 · 400 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6689	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6690	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-6691	Metformin hydrochloride	Metformin hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7162	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7163	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
0904-7164	Metformin Hydrochloride	Metformin Hydrochloride	Major Pharmaceuticals	ANDA	Current
10544-133	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal, Inc.	ANDA	Current
10544-254	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
10544-589	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
10544-947	Metformin Hydrochloride	Metformin Hydrochloride	Blenheim Pharmacal Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-102	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-103	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-104	metformin hydrochloride	metformin hydrochloride	Heritage Pharmaceuticals Inc.	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-009	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42708-018	Metformin HCl	Metformin HCl	QPharma Inc	ANDA	Current
42806-313	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-313	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-314	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-314	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-315	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-315	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
43063-889	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-889	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	Metformin hydrochloride	Metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-898	metformin hydrochloride	metformin hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
45865-517	Metformin hydrochloride	Metformin hydrochloride	Medsource Pharmaceuticals	ANDA	Current
49999-116	metformin hydrochloride	metformin hydrochloride	Quality Care Products, LLC	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0766	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0769	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-0775	Metformin hydrochloride	Metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3050	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3064	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3064	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-3579	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4891	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4892	Metformin HCl	Metformin HCl	A-S Medication Solutions	ANDA	Current
50090-4943	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4973	metformin hydrochloride	metformin hydrochloride	A-S Medication Solutions	ANDA	Current
50436-9054	Metformin hydrochloride	metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9054	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9055	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50436-9056	Metformin hydrochloride	Metformin hydrochloride	Unit Dose Services	ANDA	Current
50742-154	Metformin hydrochloride	Metformin hydrochloride	Ingenus Pharmaceuticals, LLC	ANDA	Current