Application 213320

Type: ANDA
Sponsor: HARMAN FINOCHEM

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
A213320-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03
A213320-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03
A213320-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213320-001	AB
A213320-002	AB
A213320-003	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 3 · 99 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	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2021-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213320-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2021-12-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A213320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213320-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213320-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213320-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213320-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213320-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213320-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213320-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213320-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213320-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213320-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213320-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213320-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213320-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213320-001	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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4182bcf0-1f9a-4f3a-9428-86b5d757954f	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	14450912-54b5-4fc3-ba65-77ece864b2e7	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	QPharma Inc	53bde438-4277-f418-e063-6394a90a5ea2	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	4d087f00-580b-4b9d-80d9-f97930153e72	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	1e7ab8da-4ece-499c-b0fb-34e37d991c1c	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abd0dad9-5f29-4102-a099-dce7bdddb98b	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	239834b0-121a-4903-b3ee-90bb4db4753b	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	A-S Medication Solutions	5f2023d2-05ae-489d-9e18-fb75057496bc	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5073c482-952c-400c-afff-64380f133bc8	2026-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	e3e9b582-fd15-4fe0-a210-398d9149696e	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b63bfafa-db4c-4fb8-84cd-ff73a5e7d320	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Ascend Laboratories, LLC	8c7835fa-3f68-4850-b1da-34893bafb485	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3cbb802d-d493-255e-e063-6294a90a32f2	2025-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
Metformin HCL	METFORMIN HCL	Direct_Rx	2ffeb25a-76a9-01e6-e063-6394a90ae332	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
Metformin HCL	METFORMIN HCL	Direct_Rx	3ac4e864-4b8a-13b1-e063-6294a90ada66	2025-07-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	Coupler LLC	2d7d9364-e71d-4ef6-e063-6394a90af841	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0865f83f-0f34-0690-e063-6294a90abf04	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0b3d5420-d60c-8385-e063-6394a90abb6c	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	289dc8ec-42c8-1d09-e063-6394a90a97f0	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0710e208-5b2c-3c72-e063-6394a90a4dac	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213320 application number: ANDA213320

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66064-1040	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1040	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1041	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1041	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1042	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current
66064-1042	METFORMIN HYDROCHLORIDE	metformin hydrochloride	Harman Finochem Limited	ANDA	Current