Application 209882

Type: ANDA
Sponsor: LAURUS LABS LTD

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
A209882-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27
A209882-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27
A209882-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209882-001	AB
A209882-002	AB
A209882-003	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	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2018-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209882-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2018-08-27	`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	A209882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209882-001	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 · 19 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	f4fc759a-057e-4b5d-b8ab-13bc5eeb24e4	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	400ff9dc-9789-44ac-afb5-730b632a1667	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Laurus Labs Limited	c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882 ndc (product): 42385-948 ndc (product): 42385-949 ndc (product): 42385-947
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	be023bca-511e-4801-bd2b-e30dd1408772	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin HCL	METFORMIN HCL	Direct_Rx	498ac5fc-14be-d36a-e063-6394a90a3012	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	8c248958-6c01-455e-89f5-959facb272ed	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	f59ceea4-a84a-4082-8e73-7c6f340c28d6	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	192970d3-826a-4b69-a525-9742794dc19c	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ca71c133-6c38-4b9e-80af-1949634157f4	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	0178b9dd-bafa-9e81-e063-6294a90a88b0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	REMEDYREPACK INC.	bfd6ec0f-8264-4877-aa6d-f347f53bc426	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Coupler LLC	3eeee3b7-188a-05a0-e063-6294a90a1853	2025-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e1ebb146-acfd-4301-a79c-f5bb243f8575	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	33155746-c2ef-12f4-e063-6294a90a039c	2025-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0f251f2c-97f3-4048-84f2-81fea03685aa	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	286d959a-51cb-4dbd-a3e8-1ea2f00b54c7	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	ed6e6f87-ddd7-4c9d-a263-47154d3a9478	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	c2783b59-7b20-4d4c-a3ca-03ed60dcf2c3	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	2be73d5e-7682-4ad3-831b-8c1ea73e38de	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209882 application number: ANDA209882

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42385-902	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-903	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-904	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-947	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-947	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-947	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-948	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-948	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-948	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-949	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-949	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
42385-949	Metformin Hydrochloride	Metformin Hydrochloride	Laurus Labs Limited	ANDA	Current
68071-2316	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2316	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7867	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7867	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7889	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7889	Metformin Hydrochloride	Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-1821	Metformin Hydrochloride	Metformin Hydrochloride	Bryant Ranch Prepack	ANDA	Current