Application 021410

Type: NDA
Sponsor: SB PHARMCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS	Approval date
N021410-001	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10
N021410-002	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10
N021410-003	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10
N021410-004	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25
N021410-005	AVANDAMET	METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25

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 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021410-001	AVANDAMET	500MG;EQ 1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021410-002	AVANDAMET	500MG;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021410-003	AVANDAMET	500MG;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2002-10-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021410-004	AVANDAMET	1GM;EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021410-005	AVANDAMET	1GM;EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-25	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021410-002	8236345	2022-10-07	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021410-003	8236345	2022-10-07	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021410-004	8236345	2022-10-07	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021410-005	8236345	2022-10-07	Drug product		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021410-002	8236345	2022-10-07	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021410-003	8236345	2022-10-07	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021410-004	8236345	2022-10-07	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021410-005	8236345	2022-10-07	Drug product		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021410-002	8236345	2022-10-07	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021410-003	8236345	2022-10-07	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021410-004	8236345	2022-10-07	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021410-005	8236345	2022-10-07	Drug product		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021410-002	8236345	2022-10-07	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021410-003	8236345	2022-10-07	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021410-004	8236345	2022-10-07	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021410-005	8236345	2022-10-07	Drug product		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021410-002	8236345	2022-10-07	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021410-003	8236345	2022-10-07	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021410-004	8236345	2022-10-07	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021410-005	8236345	2022-10-07	Drug product		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021410-002	8236345	2022-10-07	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021410-003	8236345	2022-10-07	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021410-004	8236345	2022-10-07	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021410-005	8236345	2022-10-07	Drug product		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021410-002	8236345	2022-10-07	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021410-003	8236345	2022-10-07	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021410-004	8236345	2022-10-07	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021410-005	8236345	2022-10-07	Drug product		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021410-001	8236345	2022-10-07	Drug product	2012-08-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021410-002	8236345	2022-10-07	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021410-003	8236345	2022-10-07	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021410-004	8236345	2022-10-07	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021410-005	8236345	2022-10-07	Drug product		`5aa47cf7b7d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47950	SUPPL	2017-04-12
47932	SUPPL	2017-04-11
47929	SUPPL	2017-04-11
5289	SUPPL	2015-12-17
36850	SUPPL	2014-05-12
15397	SUPPL	2014-05-12
15396	SUPPL	2014-05-12
27701	SUPPL	2014-05-08
27700	SUPPL	2014-05-08
5288	SUPPL	2014-05-08
5287	SUPPL	2013-09-19
27699	SUPPL	2013-01-30
36849	SUPPL	2012-06-06
5286	SUPPL	2012-06-04
27698	SUPPL	2011-11-21
15395	SUPPL	2011-11-16
27697	SUPPL	2011-05-24
15394	SUPPL	2011-05-17
36848	SUPPL	2011-02-04
5285	SUPPL	2011-02-03
42141	SUPPL	2009-09-14
15393	SUPPL	2008-12-04
5284	SUPPL	2008-12-04
23655	ORIG	2008-02-21
15392	SUPPL	2007-09-26
27696	SUPPL	2007-09-25
36847	SUPPL	2007-08-22
5283	SUPPL	2007-08-22
5282	SUPPL	2007-05-01
36846	SUPPL	2007-04-25
27695	SUPPL	2007-02-12
15391	SUPPL	2007-02-02
36844	SUPPL	2006-05-22
5280	SUPPL	2006-05-22
5281	SUPPL	2006-04-21
36845	SUPPL	2006-04-20
5279	SUPPL	2005-03-01
36843	SUPPL	2005-01-11
36842	SUPPL	2004-05-27
15390	SUPPL	2004-05-27
27694	SUPPL	2004-05-26
5278	SUPPL	2004-05-26
15389	SUPPL	2003-08-28
5277	SUPPL	2003-08-28
42140	ORIG	2003-04-30
36841	ORIG	2002-10-10
27693	ORIG	2000-05-09