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 1 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	5538e9df-0983-9281-e063-6394a90a9249	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1e8136e0-cc98-41e4-ad4b-a8fc27fb4daa	2026-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 70518-3084
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	c8e50300-1838-4c51-8d9d-ebbaaf0f3991	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	59a4ccda-5487-4ac4-9373-0c0fc8b7c88b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 70518-3101
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	30658e19-8e6e-49aa-a007-e414224797c5	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 70518-2833
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Cardinal Health 107, LLC	46cb7e3f-c739-433d-9dbe-427c2d95bef1	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	5aa1c86c-f2c8-49b1-8f81-47b11386c5d3	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	PD-Rx Pharmaceuticals, Inc.	fb890205-5d43-41eb-97b2-fb0dcdd3a950	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 72789-192
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE TABLET	Granules India Ltd	8cd5555c-f6b2-28d8-e053-2a95a90a5f1e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Unit Dose Solutions, Inc.	552ad61d-bafd-478d-e063-6294a90a02f9	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Unit Dose Solutions, Inc.	552df462-6dcb-e6f2-e063-6294a90aacfe	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Major Pharmaceuticals	5e783025-bf6d-465e-bf58-bcd253afad2c	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	62ca8af4-ff91-4bf6-b7c6-895b3b5ce8c3	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	902d1bc4-3f1f-4a1a-86d7-cf98c56a3684	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	33550b88-d4bb-4ce6-a7db-07c966f6984f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	53e950f5-c58f-78e3-e063-6294a90a53e9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin HCl	METFORMIN HCL	Proficient Rx LP	d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564 ndc (product): 71205-562 ndc (product): 71205-567
Metformin HCl	METFORMIN HCL	Northwind Health Company, LLC	13b1e35f-d047-8ddc-e063-6394a90a24dd	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	51285096-e2ce-0f3c-e063-6394a90a35d4	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090564 application number: ANDA090564
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Granules Pharmaceuticals Inc.	2387a618-24d8-4813-aa83-9114edb35374	2026-04-16	Boxed warning, 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 5 of 5 · 400 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2833	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3084	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3084	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3084	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3101	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3101	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3101	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3101	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70795-1160	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC.	ANDA	Current
70795-1160	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC.	ANDA	Current
70795-1170	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC.	ANDA	Current
70795-1170	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	GRAXCELL PHARMACEUTICAL, LLC.	ANDA	Current
70882-124	Metformin HCl	Metformin HCl	Cambridge Therapeutics Technologies, LLC	ANDA	Current
70934-135	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-135	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-135	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-135	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-136	Metformin hydrochloride	Metformin hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-136	Metformin hydrochloride	Metformin hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-136	metformin hydrochloride	metformin hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-207	Metformin hydrochloride	Metformin hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-207	Metformin hydrochloride	Metformin hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-207	metformin hydrochloride	metformin hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-212	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-212	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-212	Metformin HCl	Metformin HCl	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-760	metformin hydrochloride	metformin hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-784	metformin hydrochloride	metformin hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-830	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-945	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-142	Metformin hydrochloride	Metformin hydrochloride	Proficient Rx LP	ANDA	Current
71205-142	Metformin hydrochloride	Metformin hydrochloride	Proficient Rx LP	ANDA	Current
71205-548	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-548	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-555	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-555	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-555	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-555	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-562	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-562	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-562	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-567	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-567	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-567	Metformin HCl	Metformin HCl	Proficient Rx LP	ANDA	Current
71205-622	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-622	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0085	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0085	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0085	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0250	Metformin hydrochloride	metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0250	Metformin hydrochloride	metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0250	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0859	Metformin hydrochloride	metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0859	Metformin hydrochloride	Metformin hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1072	Metformin HCl	Metformin HCl	Bryant Ranch Prepack	ANDA	Current
71335-1983	Metformin HCl	Metformin HCl	Bryant Ranch Prepack	ANDA	Current
71610-212	Metformin hydrochloride	Metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-467	metformin hydrochloride	metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-673	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71709-110	Metformin Hydrochloride	Metformin Hydrochloride	Metcure Pharmaceuticals, Inc.	ANDA	Current
71709-111	Metformin Hydrochloride	Metformin Hydrochloride	Metcure Pharmaceuticals, Inc.	ANDA	Current
71709-112	Metformin Hydrochloride	Metformin Hydrochloride	Metcure Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-189	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-192	Metformin HCl	Metformin HCl	PD-Rx Pharmaceuticals, Inc.	ANDA	Current