Application 075972

Type: ANDA
Sponsor: CHARTWELL LIFE SCI

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
004	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	750MG	No	No
005	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	TABLET;ORAL	625MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075972-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24
A075972-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24
A075972-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24
A075972-004	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2002-01-24
A075972-005	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2002-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A075972-001	AB
A075972-002	AB
A075972-003	AB
A075972-004	AB
A075972-005	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 6 · 205 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	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL	AB	2002-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-004	METFORMIN HYDROCHLORIDE	750MG	TABLET / ORAL		2002-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-005	METFORMIN HYDROCHLORIDE	625MG	TABLET / ORAL		2002-01-24	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 127 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	A075972-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075972-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075972-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075972-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075972-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075972-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075972-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075972-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075972-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075972-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075972-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075972-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075972-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075972-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075972-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075972-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075972-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075972-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075972-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075972-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075972-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075972-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075972-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075972-002	AB	1	`1e350fbaab3a…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Chartwell RX, LLC	4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075972 application number: ANDA075972 ndc (product): 62135-683 ndc (product): 62135-682 ndc (product): 62135-684 ndc (product): 62135-681 ndc (product): 62135-680
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	Lifsa Drugs, LLC	a2385bcd-0943-4411-8658-c22b50360385	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075972 application number: ANDA075972 ndc (product): 72336-064

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62135-680	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-680	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-681	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-681	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-682	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-682	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-683	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-683	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-684	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
62135-684	Metformin Hydrochloride	Metformin Hydrochloride	Chartwell RX, LLC	ANDA	Current
72336-064	Metformin Hydrochloride	Metformin Hydrochloride	LifSa Drugs, LLC	ANDA	Current