Application 209674

Type: ANDA
Sponsor: NOVAST LABS

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	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209674-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-11-02
A209674-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2		2018-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209674-001	AB2
A209674-002	AB2

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 · 82 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	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209674-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209674-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2018-11-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A209674-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209674-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209674-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209674-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209674-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209674-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209674-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209674-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209674-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209674-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209674-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209674-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209674-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209674-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209674-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209674-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209674-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209674-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209674-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209674-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209674-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209674-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209674-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209674-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209674-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209674-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209674-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209674-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209674-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209674-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209674-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209674-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209674-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209674-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209674-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209674-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209674-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209674-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209674-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209674-002	AB2	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin	METFORMIN	REMEDYREPACK INC.	27f603ec-25e6-4270-a7a3-34a64a76f7ef	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209674 application number: ANDA209674
Metformin	METFORMIN	Ingenus Pharmaceuticals, LLC	49a0b5c2-ebaf-4c4c-905f-dfd1962ac647	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209674 application number: ANDA209674 ndc (product): 50742-633 ndc (product): 50742-634
Metformin	METFORMIN	Coupler LLC	3edc9b51-ddee-61f8-e063-6294a90ad3c5	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209674 application number: ANDA209674
Metformin	METFORMIN	Coupler LLC	33ecddbe-860a-6ca8-e063-6294a90aac64	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209674 application number: ANDA209674

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
50742-633	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-633	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-633	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-634	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-634	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current
50742-634	Metformin	metformin	Ingenus Pharmaceuticals, LLC	ANDA	Current