Application 202917

Type: ANDA
Sponsor: SUN PHARM

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 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
A202917-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL			2016-08-01
A202917-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL			2016-08-01

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL		2016-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202917-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202917-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB3	2016-08-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202917-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202917-002	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202917-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202917-002	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202917-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202917-002	AB3	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202917-001	AB3	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202917-002	AB3	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202917-001	AB3	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202917-002	AB3	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202917-001	AB3	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202917-002	AB3	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202917-001	AB3	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202917-002	AB3	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202917-001	AB3	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202917-002	AB3	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202917-001	AB3	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202917-002	AB3	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202917-001	AB3	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202917-002	AB3	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202917-001	AB3	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202917-002	AB3	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202917-001	AB3	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202917-002	AB3	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202917-001	AB3	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202917-002	AB3	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202917-001	AB3	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202917-002	AB3	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202917-001	AB3	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202917-002	AB3	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202917-001	AB3	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202917-002	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202917-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A202917-002	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202917-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A202917-002	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202917-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A202917-002	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202917-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202917-002	AB3	1	`3f01610625f2…`

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	Sun Pharmaceutical Industries, Inc.	52c18b5c-2322-4b22-a36e-3c573d609dd0	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202917 application number: ANDA202917 ndc (product): 47335-305 ndc (product): 47335-306

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-938	Metformin Hydrochloride	Metformin Hydrochloride	NorthStar RxLLC	ANDA	Current
16714-939	Metformin Hydrochloride	Metformin Hydrochloride	NorthStar RxLLC	ANDA	Current
47335-305	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-305	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-305	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-306	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-306	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-306	Metformin Hydrochloride	Metformin Hydrochloride	Sun Pharmaceutical Industries, Inc.	ANDA	Current