FDA.reportPublic FDA data

Application 021071

Type
NDA
Sponsor
SB PHARMCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 2MG BASEYesNo
003AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 4MG BASEYesNo
004AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 8MG BASEYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021071-002AVANDIAROSIGLITAZONE MALEATEEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25
N021071-003AVANDIAROSIGLITAZONE MALEATEEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25
N021071-004AVANDIAROSIGLITAZONE MALEATEEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021071-002AVANDIAEQ 2MG BASETABLET / ORALRLD1999-05-25f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021071-003AVANDIAEQ 4MG BASETABLET / ORALRLD1999-05-25f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021071-004AVANDIAEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021071-002AVANDIAEQ 2MG BASETABLET / ORALRLD1999-05-25e64feba35796…
2022-09-29 23:25 UTC2022-09N021071-003AVANDIAEQ 4MG BASETABLET / ORALRLD1999-05-25e64feba35796…
2022-09-29 23:25 UTC2022-09N021071-004AVANDIAEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021071-002AVANDIAEQ 2MG BASETABLET / ORALRLD1999-05-25cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021071-003AVANDIAEQ 4MG BASETABLET / ORALRLD1999-05-25cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021071-004AVANDIAEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021071-002AVANDIAEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021071-003AVANDIAEQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021071-004AVANDIAEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1999-05-25a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021071-00273583662020-04-19Drug substance, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021071-0027358366*PED2020-10-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021071-00373583662020-04-19Drug substance, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021071-0037358366*PED2020-10-19Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021071-00473583662020-04-19Drug substance, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021071-0047358366*PED2020-10-19Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021071-00273583662020-04-19Drug substance, Delist requested8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021071-0027358366*PED2020-10-19Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021071-00373583662020-04-19Drug substance, Delist requested8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021071-0037358366*PED2020-10-19Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021071-00473583662020-04-19Drug substance, Delist requested8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021071-0047358366*PED2020-10-19Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021071-00273583662020-04-19Drug substance, Delist requestedc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021071-0027358366*PED2020-10-19Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021071-00373583662020-04-19Drug substance, Delist requestedc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021071-0037358366*PED2020-10-19Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021071-00473583662020-04-19Drug substance, Delist requestedc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021071-0047358366*PED2020-10-19Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021071-00273583662020-04-19Drug substance, Delist requested3f01610625f2…
2019-12-14 00:12 UTC2019-12N021071-0027358366*PED2020-10-19Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021071-00373583662020-04-19Drug substance, Delist requested3f01610625f2…
2019-12-14 00:12 UTC2019-12N021071-0037358366*PED2020-10-19Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021071-00473583662020-04-19Drug substance, Delist requested3f01610625f2…
2019-12-14 00:12 UTC2019-12N021071-0047358366*PED2020-10-19Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021071-00273583662020-04-19Drug substance, Delist requestedb00525d2431f…
2019-09-15 20:21 UTC2019-09N021071-0027358366*PED2020-10-19Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021071-00373583662020-04-19Drug substance, Delist requestedb00525d2431f…
2019-09-15 20:21 UTC2019-09N021071-0037358366*PED2020-10-19Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021071-00473583662020-04-19Drug substance, Delist requestedb00525d2431f…
2019-09-15 20:21 UTC2019-09N021071-0047358366*PED2020-10-19Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021071-00273583662020-04-19Drug substance, Delist requestedea99ee380514…
2019-07-19 19:46 UTC2019-07N021071-0027358366*PED2020-10-19Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021071-00373583662020-04-19Drug substance, Delist requestedea99ee380514…
2019-07-19 19:46 UTC2019-07N021071-0037358366*PED2020-10-19Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021071-00473583662020-04-19Drug substance, Delist requestedea99ee380514…
2019-07-19 19:46 UTC2019-07N021071-0047358366*PED2020-10-19Pediatric extensionea99ee380514…

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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57600SUPPL2019-02-14
57494SUPPL2019-02-07
57493SUPPL2019-02-07
45381SUPPL2016-09-21
45354SUPPL2016-09-21
26637SUPPL2015-12-17
36012SUPPL2014-05-12
36011SUPPL2014-05-12
14283SUPPL2014-05-12
26636SUPPL2014-05-08
26635SUPPL2014-05-08
4203SUPPL2014-05-08
44993SUPPL2014-05-07
4202SUPPL2013-09-19
4201SUPPL2013-01-30
14282SUPPL2012-06-06
4200SUPPL2012-06-04
4199SUPPL2011-11-21
36010SUPPL2011-11-16
26634SUPPL2011-05-24
36009SUPPL2011-05-17
36008SUPPL2011-02-04
4198SUPPL2011-02-03
41921SUPPL2009-09-14
14281SUPPL2008-10-31
26633SUPPL2008-10-21
26630SUPPL2008-07-14
14279SUPPL2008-07-14
36007SUPPL2008-02-25
26632SUPPL2008-02-25
44092ORIG2008-02-21
36005SUPPL2008-01-18
4196SUPPL2008-01-18
36006SUPPL2007-11-19
4197SUPPL2007-11-19
14280SUPPL2007-09-26
4195SUPPL2007-09-25
26631SUPPL2007-08-17
36004SUPPL2007-08-15
21406SUPPL2007-07-27
26629SUPPL2007-05-01
36003SUPPL2007-04-25
36002SUPPL2006-06-20
26628SUPPL2006-06-20
14278SUPPL2006-06-20
4194SUPPL2006-06-20
36001SUPPL2006-04-25
4193SUPPL2006-04-25
26627SUPPL2005-08-03
14277SUPPL2005-08-03
14274SUPPL2005-05-17
4191SUPPL2005-05-17
26626SUPPL2005-03-03
14275SUPPL2005-03-03
14276SUPPL2005-01-11
4192SUPPL2005-01-11
21405SUPPL2004-05-27
21404ORIG2004-05-27
4190SUPPL2004-05-26
26625SUPPL2003-03-10
36000SUPPL2003-02-27
4189SUPPL2002-12-03
35999SUPPL2000-04-04
26624SUPPL2000-04-04
35998ORIG1999-05-25
26623ORIG1999-05-25
63740SUPPL1900-01-01
52185SUPPL1900-01-01
52184SUPPL1900-01-01
52183SUPPL1900-01-01
52182SUPPL1900-01-01
52180SUPPL1900-01-01