Application 206145

Type: ANDA
Sponsor: ALKEM LABS LTD

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 42.

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
A206145-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22
A206145-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206145-001	AB1
A206145-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB		2018-10-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206145-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB1		2018-10-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206145-002	METFORMIN HYDROCHLORIDE	750MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-10-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206145-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206145-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206145-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206145-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206145-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206145-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206145-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206145-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206145-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206145-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206145-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206145-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206145-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206145-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206145-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206145-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206145-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206145-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206145-001	AB1	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206145-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-001	AB1	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206145-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206145-001	AB1	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206145-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206145-001	AB1	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206145-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206145-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206145-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206145-001	AB1	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206145-002	AB	1	`bb7c543d1eb4…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Quallent Pharmaceuticals Health LLC	6864ff5a-7512-4a4f-ad26-b2b9c5843414	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	64650d2c-2bec-4470-b250-29d01caa1ebe	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f2a27d7a-ade4-421f-e053-2a95a90a01a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	f5ef117c-27ff-c21e-e053-2995a90ae145	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	0ff1ba75-3c86-4baf-a6b1-1bb883839866	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 67877-413 ndc (product): 67877-414
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	53ba7031-be87-47a5-ade7-494c6c489cc6	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	056072d8-6228-4914-831d-ee7c0661b742	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 50090-5246
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d60139c2-fd35-4ab4-af7e-7410481edc2e	2023-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 50090-5397
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	a57e2890-d83b-488c-b221-2e8f8a78ed16	2023-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 50090-5396
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Proficient Rx LP	474e2900-43bf-4ebe-9d29-4a7adb8a9429	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 71205-686
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e298db3-439e-4e91-8f9e-01c3cdc4d552	2021-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206145 application number: ANDA206145 ndc (product): 71610-578

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8415	Metformin Hydrochloride	Metformin Hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
50090-5246	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5246	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5396	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5396	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5396	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5396	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5397	Metformin Hydrochloride	Metformin Hydrochloride	A-S Medication Solutions	ANDA	Current
60687-640	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
60687-640	Metformin Hydrochloride	Metformin Hydrochloride	American Health Packaging	ANDA	Current
67877-413	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-413	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-413	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-414	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-414	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
67877-414	Metformin Hydrochloride	Metformin Hydrochloride	Ascend Laboratories, LLC	ANDA	Current
68071-2829	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2829	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2829	Metformin Hydrochloride	Metformin Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3599	Metformin Hydrochloride	Metformin Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-788	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-788	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-792	Metformin Hydrochloride	Metformin Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71205-686	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71205-686	Metformin Hydrochloride	Metformin Hydrochloride	Proficient Rx LP	ANDA	Current
71610-578	Metformin Hydrochloride	Metformin Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current