Application 021700

Type: NDA
Sponsor: SB PHARMCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	TABLET;ORAL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 44.

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
N021700-001	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23
N021700-002	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23
N021700-003	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23
N021700-004	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30
N021700-005	AVANDARYL	GLIMEPIRIDE; ROSIGLITAZONE MALEATE	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30

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 5 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021700-001	AVANDARYL	1MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021700-002	AVANDARYL	2MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021700-003	AVANDARYL	4MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2005-11-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021700-004	AVANDARYL	2MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021700-005	AVANDARYL	4MG;8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2007-03-30	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021700-001	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-001	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-002	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-002	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-003	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-003	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-004	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-004	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-005	7358366	2020-04-19	Drug substance, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021700-005	7358366*PED	2020-10-19	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021700-001	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-001	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-002	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-002	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-003	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-003	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-004	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-004	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-005	7358366	2020-04-19	Drug substance, Delist requested	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021700-005	7358366*PED	2020-10-19	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021700-001	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-001	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-002	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-002	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-003	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-003	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-004	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-004	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-005	7358366	2020-04-19	Drug substance, Delist requested	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021700-005	7358366*PED	2020-10-19	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021700-001	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-001	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-002	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-002	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-003	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-003	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-004	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-004	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-005	7358366	2020-04-19	Drug substance, Delist requested	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021700-005	7358366*PED	2020-10-19	Pediatric extension	`3f01610625f2…`

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
56230	SUPPL	2018-11-01
28411	SUPPL	2015-12-17
37487	SUPPL	2015-03-19
28410	SUPPL	2015-03-17
37486	SUPPL	2014-05-12
37485	SUPPL	2014-05-12
16225	SUPPL	2014-05-12
28409	SUPPL	2014-05-08
28408	SUPPL	2014-05-08
6019	SUPPL	2014-05-08
6018	SUPPL	2013-09-19
6017	SUPPL	2013-01-30
37484	SUPPL	2012-06-06
6016	SUPPL	2012-06-04
6015	SUPPL	2011-11-21
16224	SUPPL	2011-11-16
6014	SUPPL	2011-05-24
16223	SUPPL	2011-05-17
16222	SUPPL	2011-02-04
6013	SUPPL	2011-02-03
37483	SUPPL	2009-12-10
37482	SUPPL	2008-12-04
28407	SUPPL	2008-12-04
44144	ORIG	2008-02-21
28405	SUPPL	2007-09-25
37481	SUPPL	2007-08-22
28406	SUPPL	2007-08-22
42275	ORIG	2007-07-02
28404	SUPPL	2007-04-09
28403	SUPPL	2006-10-26
37480	SUPPL	2006-10-25
37479	SUPPL	2006-06-20
28402	SUPPL	2006-06-20
16221	SUPPL	2006-06-20
6012	SUPPL	2006-06-20
37478	ORIG	2005-11-30
6011	ORIG	2005-11-30