Application 021192

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LESCOL XL	FLUVASTATIN SODIUM	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021192-001	LESCOL XL	FLUVASTATIN SODIUM	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021192-001	AB

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 2 · 43 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
2022-09-29 23:25 UTC	2022-09	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021192-001	LESCOL XL	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2000-10-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021192-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021192-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021192-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021192-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021192-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021192-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021192-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021192-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021192-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021192-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021192-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021192-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021192-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021192-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021192-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021192-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021192-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021192-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021192-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021192-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021192-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021192-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021192-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021192-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021192-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021192-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021192-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021192-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021192-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021192-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021192-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021192-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021192-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021192-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021192-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021192-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021192-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021192-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021192-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021192-001	AB	1	`f41ea6bd6efb…`

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	N021192-001	6242003	2020-04-13		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021192-001	6242003	2020-04-13		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021192-001	6242003	2020-04-13		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021192-001	6242003	2020-04-13		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021192-001	6242003	2020-04-13		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021192-001	6242003	2020-04-13		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021192-001	6242003*PED	2020-10-13	Pediatric extension	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FLUVASTATIN SODIUM ER	FLUVASTATIN SODIUM	Sandoz Inc	5ab4296c-87c2-4c64-b218-d620eef51310	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021192 application number: NDA021192 ndc (product): 0781-8017
Lescol XL	FLUVASTATIN SODIUM	Sandoz Inc	726ea2db-f1b0-4b73-a515-02157db88a42	2023-12-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021192 application number: NDA021192

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0354	Lescol	fluvastatin sodium	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5370	FLUVASTATIN SODIUM	fluvastatin sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8017	FLUVASTATIN SODIUM	fluvastatin sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8017	FLUVASTATIN SODIUM	fluvastatin sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-8017	FLUVASTATIN SODIUM	fluvastatin sodium	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
68151-4471	Lescol	fluvastatin sodium	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76680	SUPPL	2023-11-29
76674	SUPPL	2023-11-29
64727	SUPPL	2020-09-29
64700	SUPPL	2020-09-28
49282	SUPPL	2017-08-08
49273	SUPPL	2017-08-08
36322	SUPPL	2012-11-06
4608	SUPPL	2012-11-05
21502	SUPPL	2012-03-30
44472	SUPPL	2012-02-28
36321	SUPPL	2012-02-28
4607	SUPPL	2012-02-28
36320	SUPPL	2011-06-28
27032	SUPPL	2011-06-28
42014	SUPPL	2008-08-01
21501	SUPPL	2008-08-01
36319	SUPPL	2007-06-14
27031	SUPPL	2007-06-14
27030	SUPPL	2006-04-13
4605	SUPPL	2006-04-13
14617	SUPPL	2006-04-12
14616	SUPPL	2006-04-12
36318	SUPPL	2006-04-05
4606	SUPPL	2006-04-05
27029	SUPPL	2005-01-11
14615	SUPPL	2005-01-11
14612	ORIG	2004-06-08
42013	ORIG	2004-03-24
27028	SUPPL	2003-06-08
14614	SUPPL	2003-06-08
14613	SUPPL	2003-05-01
36317	SUPPL	2002-09-06
4604	SUPPL	2002-09-06
27027	ORIG	2000-10-06