Application 205096

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;ORAL	500MG	No	No
002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	850MG	No	No
003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A205096-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11
A205096-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11
A205096-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205096-001	AB
A205096-002	AB
A205096-003	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 · 123 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	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2016-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2016-07-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A205096-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205096-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205096-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205096-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205096-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205096-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205096-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205096-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205096-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205096-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205096-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205096-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205096-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205096-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205096-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205096-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205096-001	AB	1	`8072bd15b7f6…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4d4021ba-4b28-6b81-e063-6294a90a5ea7	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Precision Dose, Inc.	37ff1b8e-a434-41c0-82e1-4583842921a5	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Mullan Pharmaceutical Inc.	082b4de9-e452-fe71-e063-6394a90ac863	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f6581ce6-0f9f-4887-ae83-4c6ecde619f3	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler, LLC	32ff33ed-89ed-c391-e063-6294a90ae414	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	565610b8-a9a0-4e5e-866d-81d9501a817d	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2d2ebf52-3d5e-4fad-b7f7-c9280957574c	2024-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2bbaa0c-5b05-4335-882f-14f1b443edd7	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	54ca16e6-1213-4877-8ace-477c764c8e76	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	583dac53-65e7-4710-912a-ecd89d07ad03	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205096 application number: ANDA205096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4412	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
51224-020	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-120	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
51224-220	Metformin Hydrochloride	Metformin Hydrochloride	TAGI Pharma, Inc.	ANDA	Current
70518-3212	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3212	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3212	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3212	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3611	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-311	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-399	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-399	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-1288	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1288	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1288	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1289	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1289	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1303	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1303	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71610-210	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-278	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71717-104	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Megalith Pharmaceuticals Inc	ANDA	Current
71717-105	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Megalith Pharmaceuticals Inc	ANDA	Current
71717-106	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Megalith Pharmaceuticals Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10422	ORIG	2016-07-13