Application 020261

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LESCOL	FLUVASTATIN SODIUM	CAPSULE;ORAL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	LESCOL	FLUVASTATIN SODIUM	CAPSULE;ORAL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020261-001	LESCOL	FLUVASTATIN SODIUM	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1993-12-31
N020261-002	LESCOL	FLUVASTATIN SODIUM	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1993-12-31

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1993-12-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020261-001	LESCOL	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020261-002	LESCOL	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1993-12-31	`3a93d1ddd44b…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvastatin Sodium	FLUVASTATIN SODIUM	Lannett Company, Inc.	3565bfd3-ef9f-456d-b4be-a294a7a0f01c	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: FLUVASTATIN SODIUM
Fluvastatin Sodium	FLUVASTATIN SODIUM	Teva Pharmaceuticals USA, Inc.	cc55110f-1ad6-4f97-840d-62b3a5ac415a	2024-09-16	Warnings, Adverse reactions	Name fallback generic name: FLUVASTATIN SODIUM
FLUVASTATIN SODIUM ER	FLUVASTATIN SODIUM	Sandoz Inc	5ab4296c-87c2-4c64-b218-d620eef51310	2024-01-31	Warnings, Adverse reactions	Name fallback generic name: FLUVASTATIN SODIUM
Lescol XL	FLUVASTATIN SODIUM	Sandoz Inc	726ea2db-f1b0-4b73-a515-02157db88a42	2023-12-13	Warnings, Adverse reactions	Name fallback generic name: FLUVASTATIN SODIUM

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
49281	SUPPL	2017-08-08
49272	SUPPL	2017-08-08
34444	SUPPL	2012-11-06
2262	SUPPL	2012-11-05
41242	SUPPL	2012-03-30
44447	SUPPL	2012-02-28
24674	SUPPL	2012-02-28
12385	SUPPL	2012-02-28
34443	SUPPL	2011-06-28
2261	SUPPL	2011-06-28
41241	SUPPL	2009-09-16
41233	SUPPL	2009-09-16
41240	SUPPL	2008-08-04
20571	SUPPL	2008-08-04
20570	SUPPL	2008-08-04
41238	SUPPL	2008-04-02
41236	SUPPL	2008-04-02
41235	SUPPL	2008-02-19
20568	SUPPL	2008-02-19
20567	SUPPL	2008-02-19
20566	SUPPL	2008-02-19
20565	SUPPL	2008-02-19
20564	SUPPL	2008-02-19
20560	SUPPL	2008-02-19
20563	SUPPL	2007-09-26
20562	SUPPL	2007-09-26
20561	SUPPL	2007-09-14
41234	SUPPL	2007-07-06
20559	SUPPL	2007-07-06
12384	SUPPL	2007-06-14
2260	SUPPL	2007-06-14
20572	SUPPL	2007-04-09
24672	SUPPL	2006-04-13
2259	SUPPL	2006-04-13
34442	SUPPL	2006-04-12
12382	SUPPL	2006-04-12
24673	SUPPL	2006-04-05
12383	SUPPL	2006-04-05
24671	SUPPL	2005-01-11
12381	SUPPL	2005-01-11
24670	SUPPL	2004-06-08
20569	SUPPL	2004-06-08
12379	SUPPL	2004-06-08
34441	SUPPL	2003-06-08
2258	SUPPL	2003-06-08
34440	SUPPL	2003-04-22
12380	SUPPL	2002-09-06
2257	SUPPL	2002-09-06
2256	SUPPL	2000-12-18
34439	SUPPL	2000-10-23
2255	SUPPL	2000-10-23
41237	SUPPL	1999-05-08
41239	SUPPL	1999-03-08
24669	SUPPL	1999-03-08
2254	SUPPL	1999-03-08
51959	SUPPL	1900-01-01
51958	SUPPL	1900-01-01
51957	SUPPL	1900-01-01