Application 200690

Type: ANDA
Sponsor: MYLAN PHARMS INC

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
A200690-001	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2		2012-08-01
A200690-002	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2		2012-08-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200690-001	AB2
A200690-002	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	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200690-001	METFORMIN HYDROCHLORIDE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200690-002	METFORMIN HYDROCHLORIDE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB2	2012-08-01	`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	A200690-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200690-002	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200690-002	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200690-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200690-002	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200690-002	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200690-002	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200690-002	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200690-002	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200690-002	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200690-002	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200690-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200690-002	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200690-002	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200690-002	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200690-002	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200690-001	AB2	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200690-002	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-001	AB2	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200690-002	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200690-001	AB2	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200690-002	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200690-001	AB2	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200690-002	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200690-001	AB2	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200690-002	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200690-001	AB2	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200690-002	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200690-001	AB2	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200690-002	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metformin Hydrochloride	METFORMIN	Mylan Pharmaceuticals Inc.	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	2026-06-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200690 application number: ANDA200690 ndc (product): 0378-6001 ndc (product): 0378-6002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6001	Metformin Hydrochloride	metformin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6002	Metformin Hydrochloride	metformin	Mylan Pharmaceuticals Inc.	ANDA	Current