Application 078321

Type: ANDA
Sponsor: CSPC OUYI

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 1.

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
A078321-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2008-04-17
A078321-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2008-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078321-001	AB1
A078321-002	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 · 82 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
2026-02-19 14:30 UTC	2026-02	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1	2008-04-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	2008-04-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078321-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078321-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078321-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078321-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078321-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078321-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078321-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078321-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078321-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078321-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078321-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078321-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078321-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078321-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078321-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078321-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078321-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078321-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078321-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078321-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078321-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078321-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078321-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078321-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078321-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078321-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078321-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078321-001	AB1	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078321-002	AB	1	`782e0a99824c…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	41408f64-d366-403e-9595-464ab25c6f97	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68d0b1a6-c99e-42cf-afdf-b71ee73c4424	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	1503bbe4-0ac5-479b-9900-d38e49236bf0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 70518-2709
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4d245bc3-0add-4651-b441-86b93c5ac681	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	60142fb2-16da-4f54-a542-74f9a70b9c8b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1d0b74de-ef4c-4dd2-8019-2ddb409c60b4	2026-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	d9bac244-1725-5bf3-e053-2a95a90ac823	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 50268-550
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	AvPAK	de09f7a1-1e9f-60f4-e053-2a95a90a93d8	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 50268-551
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	ab80521b-5014-cc2a-e053-2a95a90a2003	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 51655-368
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	c568d49f-c040-4f1e-ad36-77b05ab659c3	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	bf918d78-3fb6-4d8d-b42d-538ea10bc3e4	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 68788-7205
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e55ee270-5eb9-4848-8529-9af2a79669c0	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	TAGI Pharma, Inc.	dd0ee2bf-f658-42dc-976d-49af0b1f32b5	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 51224-007 ndc (product): 51224-107
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	de4a660b-172b-4c72-9e38-5634fd03cfa7	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 71335-0776 ndc (product): 71335-0720
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	7cb47c3e-6657-4c11-8aa2-ae172e5a8529	2025-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	RedPharm Drug, Inc.	fc61bafa-a506-14ae-e053-6394a90a9c7d	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 67296-1701
METFORMIN HYDROCHLORIDE EXTENDED RELEASE	METFORMIN HYDROCHLORIDE	direct rx	a84cf1a3-3820-cd1b-e053-2995a90acf45	2025-01-22	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 72189-150
Metformin Hydrochloride Extended-Release 500mg	METFORMIN HYDROCHLORIDE	Calvin Scott & Co., Inc.	e9cd0d23-56eb-40dd-abf4-9e681ec220f5	2023-02-07	Warnings	Exact identifier application applno (ANDA): 078321 application number: ANDA078321
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	d80aa4af-a8ce-4cae-b71c-05e1de829551	2022-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 71205-186
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4d89a4ab-6cdd-4c39-92f9-a137fa27a070	2021-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078321 application number: ANDA078321 ndc (product): 71610-533

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 88 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2767	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2767	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3719	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4884	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50268-550	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-551	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50268-551	Metformin Hydrochloride	Metformin Hydrochloride	AvPAK	ANDA	Current
50436-0700	Metformin Hydrochloride	Metformin Hydrochloride	Unit Dose Services	ANDA	Current
51224-007	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-007	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-107	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-107	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51655-368	Metformin Hydrochloride	Metformin Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
51655-368	Metformin Hydrochloride	Metformin Hydrochloride	Northwind Pharmaceuticals	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
55700-734	Metformin Hydrochloride	Metformin Hydrochloride	Quality Care Products, LLC	ANDA	Current
63629-8166	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8166	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
67296-1701	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
67296-1701	Metformin Hydrochloride	Metformin Hydrochloride	RedPharm Drug, Inc.	ANDA	Current
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7204	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7205	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0512	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0844	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2709	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-083	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-117	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-134	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-134	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-141	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-141	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-186	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71335-0720	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0720	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0776	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0776	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-533	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-533	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72189-150	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	direct rx	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-059	Metformin Hydrochloride	Metformin Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current