Home Applications 021071 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 43 .
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 TE codes 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AVANDIA ROSIGLITAZONE MALEATE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-05-25 N021071-003 AVANDIA ROSIGLITAZONE MALEATE EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-05-25 N021071-004 AVANDIA ROSIGLITAZONE MALEATE EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-05-25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 2 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021071-004 AVANDIA EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1999-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 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 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 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 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 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 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021071-004 AVANDIA EQ 8MG BASE TABLET / ORAL RLD 1999-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021071-004 AVANDIA EQ 8MG BASE TABLET / ORAL RLD 1999-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021071-004 AVANDIA EQ 8MG BASE TABLET / ORAL RLD 1999-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021071-004 AVANDIA EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021071-004 AVANDIA EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021071-004 AVANDIA EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021071-004 AVANDIA EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1999-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021071-002 AVANDIA EQ 2MG BASE TABLET / ORAL RLD 1999-05-25 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021071-003 AVANDIA EQ 4MG BASE TABLET / ORAL RLD 1999-05-25 c0c555d07b60…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…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date 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