Application 075965

Type: ANDA
Sponsor: SANDOZ

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
A075965-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25
A075965-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25
A075965-003	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075965-001	AB
A075965-002	AB
A075965-003	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	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-002	METFORMIN HYDROCHLORIDE	850MG	TABLET / ORAL	AB	2002-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-003	METFORMIN HYDROCHLORIDE	1GM	TABLET / ORAL	AB	2002-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075965-001	METFORMIN HYDROCHLORIDE	500MG	TABLET / ORAL	AB	2002-01-25	`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	A075965-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075965-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075965-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075965-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075965-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075965-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075965-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075965-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075965-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075965-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075965-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075965-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075965-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075965-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075965-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075965-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075965-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075965-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075965-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075965-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN HYDROCHLORIDE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	5c2581e3-2b30-4da5-8bed-228173ca20d2	2019-01-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075965 application number: ANDA075965 ndc (product): 24658-791 ndc (product): 24658-792 ndc (product): 24658-790

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24658-790	Metformin Hydrochloride	Metformin Hydrochloride	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-791	Metformin Hydrochloride	Metformin Hydrochloride	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
24658-792	Metformin Hydrochloride	Metformin Hydrochloride	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ANDA	Current
42806-213	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-213	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-213	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-215	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-215	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-215	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-221	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-221	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
42806-221	Metformin Hydrochloride	Metformin Hydrochloride	Epic Pharma, LLC	ANDA	Current
43353-894	metformin hydrochloride	metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-936	metformin hydrochloride	metformin hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current