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002	MEVACOR	LOVASTATIN	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	MEVACOR	LOVASTATIN	TABLET;ORAL	20MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	MEVACOR	LOVASTATIN	TABLET;ORAL	40MG Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019643-002	MEVACOR	LOVASTATIN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28
N019643-003	MEVACOR	LOVASTATIN	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31
N019643-004	MEVACOR	LOVASTATIN	40MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1988-12-14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 1 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
2026-09-14 22:38:34	2026-08	N019643-002	MEVACOR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1991-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019643-003	MEVACOR	20MG Federal Register notice that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	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	`301d65b070ca…`

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 3 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	NCS HealthCare of KY, LLC dba Vangard Labs	3af47e72-082d-42ad-bde0-294f8101b45c	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4aa44b69-2946-2fb1-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	8ccb2a86-cd02-4162-e053-2995a90abe0e	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	19b2bb87-1dc7-cd72-e063-6394a90a0f73	2024-06-18	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals,Inc.	1ac7ffb9-860a-fbb6-e063-6294a90a590f	2024-06-13	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	0399c35c-513d-48e6-aa20-e8434e3b18d5	2024-01-23	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Aphena Pharma Solutions - Tennessee, LLC	7e96b174-3887-4908-9b9f-5ef93540f96a	2023-05-31	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	2b53ab6a-5770-4fd7-9aa1-f4273d4bdaeb	2022-12-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	eb3b4051-3901-461d-a982-7ecd115ba669	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	da9c25c1-f65c-4dc6-8e13-f727c50fd4e4	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	25efd38a-1495-4824-9137-a3429bc471bd	2022-07-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	4b512c0b-b2f6-4a16-bee6-7669195497ad	2021-01-04	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	c2b1b926-def3-4411-9aed-395b969028fe	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Teva Pharmaceuticals USA, Inc.	0e15feec-d27e-4861-8152-c5a8b8ccacd4	2020-08-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	027bd594-6a0a-4e6d-bd3c-4f33fdb4166a	2020-04-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Proficient Rx LP	f9e27117-db98-48bc-b7bc-fc98c9b719cf	2019-11-01	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