Application 021071

Type: NDA
Sponsor: SB PHARMCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	AVANDIA	ROSIGLITAZONE MALEATE	TABLET;ORAL	EQ 2MG BASE	Yes	No
003	AVANDIA	ROSIGLITAZONE MALEATE	TABLET;ORAL	EQ 4MG BASE	Yes	No
004	AVANDIA	ROSIGLITAZONE MALEATE	TABLET;ORAL	EQ 8MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N021071-002	AVANDIA	ROSIGLITAZONE MALEATE	EQ 2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25
N021071-003	AVANDIA	ROSIGLITAZONE MALEATE	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25
N021071-004	AVANDIA	ROSIGLITAZONE MALEATE	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25

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 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N021071-004	AVANDIA	EQ 8MG BASE	TABLET / ORAL	RLD	1999-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-004	AVANDIA	EQ 8MG BASE	TABLET / ORAL	RLD	1999-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-004	AVANDIA	EQ 8MG BASE	TABLET / ORAL	RLD	1999-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-004	AVANDIA	EQ 8MG BASE	TABLET / ORAL	RLD	1999-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021071-002	AVANDIA	EQ 2MG BASE	TABLET / ORAL	RLD	1999-05-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021071-003	AVANDIA	EQ 4MG BASE	TABLET / ORAL	RLD	1999-05-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021071-004	AVANDIA	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1999-05-25	`3a93d1ddd44b…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021071-002	7358366	2020-04-19	Drug substance, Delist requested	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-002	7358366*PED	2020-10-19	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-003	7358366	2020-04-19	Drug substance, Delist requested	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-003	7358366*PED	2020-10-19	Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-004	7358366	2020-04-19	Drug substance, Delist requested	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021071-004	7358366*PED	2020-10-19	Pediatric extension	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

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
0173-0861	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0861	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0861	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0861	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0863	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0863	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0863	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current
0173-0863	AVANDIA	rosiglitazone maleate	GlaxoSmithKline LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57600	SUPPL	2019-02-14
57494	SUPPL	2019-02-07
57493	SUPPL	2019-02-07
45381	SUPPL	2016-09-21
45354	SUPPL	2016-09-21
26637	SUPPL	2015-12-17
36012	SUPPL	2014-05-12
36011	SUPPL	2014-05-12
14283	SUPPL	2014-05-12
26636	SUPPL	2014-05-08
26635	SUPPL	2014-05-08
4203	SUPPL	2014-05-08
44993	SUPPL	2014-05-07
4202	SUPPL	2013-09-19
4201	SUPPL	2013-01-30
14282	SUPPL	2012-06-06
4200	SUPPL	2012-06-04
4199	SUPPL	2011-11-21
36010	SUPPL	2011-11-16
26634	SUPPL	2011-05-24
36009	SUPPL	2011-05-17
36008	SUPPL	2011-02-04
4198	SUPPL	2011-02-03
41921	SUPPL	2009-09-14
14281	SUPPL	2008-10-31
26633	SUPPL	2008-10-21
26630	SUPPL	2008-07-14
14279	SUPPL	2008-07-14
36007	SUPPL	2008-02-25
26632	SUPPL	2008-02-25
44092	ORIG	2008-02-21
36005	SUPPL	2008-01-18
4196	SUPPL	2008-01-18
36006	SUPPL	2007-11-19
4197	SUPPL	2007-11-19
14280	SUPPL	2007-09-26
4195	SUPPL	2007-09-25
26631	SUPPL	2007-08-17
36004	SUPPL	2007-08-15
21406	SUPPL	2007-07-27
26629	SUPPL	2007-05-01
36003	SUPPL	2007-04-25
36002	SUPPL	2006-06-20
26628	SUPPL	2006-06-20
14278	SUPPL	2006-06-20
4194	SUPPL	2006-06-20
36001	SUPPL	2006-04-25
4193	SUPPL	2006-04-25
26627	SUPPL	2005-08-03
14277	SUPPL	2005-08-03
14274	SUPPL	2005-05-17
4191	SUPPL	2005-05-17
26626	SUPPL	2005-03-03
14275	SUPPL	2005-03-03
14276	SUPPL	2005-01-11
4192	SUPPL	2005-01-11
21405	SUPPL	2004-05-27
21404	ORIG	2004-05-27
4190	SUPPL	2004-05-26
26625	SUPPL	2003-03-10
36000	SUPPL	2003-02-27
4189	SUPPL	2002-12-03
35999	SUPPL	2000-04-04
26624	SUPPL	2000-04-04
35998	ORIG	1999-05-25
26623	ORIG	1999-05-25
63740	SUPPL	1900-01-01
52185	SUPPL	1900-01-01
52184	SUPPL	1900-01-01
52183	SUPPL	1900-01-01
52182	SUPPL	1900-01-01
52180	SUPPL	1900-01-01