Application 019643

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MEVACOR	LOVASTATIN	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MEVACOR	LOVASTATIN	TABLET;ORAL	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MEVACOR	LOVASTATIN	TABLET;ORAL	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 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	RLD / RS	Approval date
N019643-002	MEVACOR	LOVASTATIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28
N019643-003	MEVACOR	LOVASTATIN	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31
N019643-004	MEVACOR	LOVASTATIN	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14

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	RLD / RS	Approval date	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019643-002	MEVACOR	10MG	TABLET / ORAL	RLD	1991-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019643-003	MEVACOR	20MG	TABLET / ORAL	RLD	1987-08-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019643-004	MEVACOR	40MG	TABLET / ORAL	RLD	1988-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019643-002	MEVACOR	10MG	TABLET / ORAL	RLD	1991-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019643-003	MEVACOR	20MG	TABLET / ORAL	RLD	1987-08-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019643-004	MEVACOR	40MG	TABLET / ORAL	RLD	1988-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019643-004	MEVACOR	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1988-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1991-03-28	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1987-08-31	`3f01610625f2…`

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 3 · 55 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	9438d8a0-ca5b-4676-aab9-d0241ccff6c9	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	e75b5808-ec66-4da7-90bc-e53611aa1b34	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals Inc.	56680dfa-abe6-4587-b222-364315fd78f4	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	397949f9-ce60-424f-9902-90e65a34f4de	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	22c9f2d8-7bcd-4415-bbc8-505720033966	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Preferred Pharmaceuticals, Inc.	ea4df37b-21e9-4dc3-83af-1be1b50bfdc9	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	030c0f79-6bb5-4876-bf8e-b7a25b25dd38	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	f5f265a6-2aa5-4205-9159-40133ae93ac0	2026-05-28	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	ff040b3c-6790-40d7-bd64-a4073b4a2045	2026-05-21	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Lupin Pharmaceuticals, Inc.	df7ddf4f-d569-431e-81f1-9129d7043150	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	REMEDYREPACK INC.	a902a95f-072a-4487-99a9-109a93f8b23c	2026-04-03	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Legacy Pharmaceutical Packaging, LLC	a4f02fa1-3281-46fa-bd52-323e2644b6f8	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	7fd9d5c7-8025-4049-8b5b-ae3d22db507f	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f308fe1c-23a9-6409-e053-2995a90abfd9	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	ca59cbd4-a4c1-aebe-e053-2a95a90ae968	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	db47ddae-c574-427f-e053-2a95a90aae48	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Northwind Health Company, LLC	f99e0b4c-e757-4ccd-e053-6294a90ab722	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Golden State Medical Supply, Inc.	91332c54-1a27-4e6b-e053-2a95a90a42cd	2025-12-15	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	06b8c398-ce2e-42c1-b1a8-73cc59a080db	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN

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
33833	SUPPL	2014-03-04
1450	SUPPL	2014-02-28
33832	SUPPL	2012-11-06
11591	SUPPL	2012-11-06
17511	SUPPL	2012-11-05
1449	SUPPL	2012-11-05
40949	SUPPL	2012-03-30
23963	SUPPL	2012-02-28
17510	SUPPL	2012-02-28
11590	SUPPL	2012-02-28
17509	SUPPL	2011-06-17
1448	SUPPL	2011-02-07
11589	SUPPL	2011-02-04
33831	SUPPL	2010-07-06
1447	SUPPL	2010-07-02
33830	SUPPL	2009-03-17
17508	SUPPL	2009-03-11
1446	SUPPL	2008-01-09
20276	SUPPL	2007-07-06
20273	SUPPL	2007-07-06
33829	SUPPL	2007-06-04
17507	SUPPL	2007-06-04
1443	SUPPL	2007-04-25
11585	SUPPL	2007-04-20
1445	SUPPL	2005-11-18
11588	SUPPL	2005-11-08
33828	SUPPL	2005-06-14
17506	SUPPL	2005-06-14
17505	SUPPL	2005-04-12
11587	SUPPL	2005-04-12
33826	SUPPL	2003-04-17
11586	SUPPL	2003-04-16
33827	SUPPL	2002-09-20
1444	SUPPL	2002-09-20
33825	SUPPL	2002-02-14
17504	SUPPL	2002-02-14
40948	SUPPL	2001-08-17
20275	SUPPL	2001-08-17
40947	SUPPL	2000-05-17
17503	SUPPL	1999-03-11
40945	SUPPL	1997-08-12
40946	SUPPL	1997-06-25
20274	SUPPL	1997-06-25