Application 021316

Type: NDA
Sponsor: COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALTOPREV	LOVASTATIN	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
002	ALTOPREV	LOVASTATIN	TABLET, EXTENDED RELEASE;ORAL	20MG	Yes	No
003	ALTOPREV	LOVASTATIN	TABLET, EXTENDED RELEASE;ORAL	40MG	Yes	No
004	ALTOPREV	LOVASTATIN	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021316-001	ALTOPREV	LOVASTATIN	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26
N021316-002	ALTOPREV	LOVASTATIN	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26
N021316-003	ALTOPREV	LOVASTATIN	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26
N021316-004	ALTOPREV	LOVASTATIN	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26

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 5 · 172 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	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-001	ALTOPREV	10MG	TABLET, EXTENDED RELEASE / ORAL		2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-002	ALTOPREV	20MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-003	ALTOPREV	40MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2002-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021316-004	ALTOPREV	60MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2002-06-26	`5bbf6a4d5a75…`

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 2 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lovastatin	LOVASTATIN	A-S Medication Solutions	dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	bfb889a4-5751-4706-9fa7-f48672c1bc08	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	220a9b3c-c583-49e3-8bf0-d0c97dc9b829	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	c37206ae-52f1-4192-9ab9-3044247cf58d	2025-03-13	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	ac86821f-d741-4ab1-bd03-ce8797dd4f34	2025-03-12	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	70e2bf86-4a78-4dfb-b6b1-8eb95f63684d	2025-03-06	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	PD-Rx Pharmaceuticals, Inc.	eea93a4b-f804-4b9c-aabf-e906f03c1e80	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eff3e5e-8746-048e-e063-6294a90a38c4	2025-02-25	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	2eeb34ac-f973-e7d9-e063-6294a90a076e	2025-02-24	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	50217921-97a7-6ff2-e054-00144ff88e88	2025-02-04	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Carlsbad Technology, Inc.	0a680e13-0356-4e08-a7fe-78b96ba51b9d	2025-01-07	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	4ff981e8-5c86-4b86-baa1-825551905ed8	2024-12-12	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	A-S Medication Solutions	02aae38d-ee9d-4c09-a155-b69f221ed3e9	2024-10-15	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	c871a6a7-67a4-4ac1-b102-3f1604625c7d	2024-09-12	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	415c2698-7787-49f8-e054-00144ff88e88	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	NuCare Pharmaceuticals, Inc.	4444573e-9df1-01e6-e054-00144ff8d46c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	8d8199ca-df39-4eb8-a905-dee3ab7e2973	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	5684ceb8-a5b2-4fb4-92be-14aabcea3871	2024-08-09	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	ad905651-6e3a-4140-aa37-d91e5f37c0f0	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN
Lovastatin	LOVASTATIN	Bryant Ranch Prepack	a623c1da-e94e-41be-900c-9e74376d36c8	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: LOVASTATIN

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
70515-628	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-628	Altoprev	lovastatin	Covis Pharma US, Inc	NDA	Current
70515-628	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-628	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-629	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-629	Altoprev	lovastatin	Covis Pharma US, Inc	NDA	Current
70515-629	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-629	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-630	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-630	Altoprev	lovastatin	Covis Pharma US, Inc	NDA	Current
70515-630	Altoprev	lovastatin	Covis Pharma	NDA	Current
70515-630	Altoprev	lovastatin	Covis Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77836	SUPPL	2024-03-15
64717	SUPPL	2020-09-29
64701	SUPPL	2020-09-28
52805	SUPPL	2018-03-02
52795	SUPPL	2018-03-02
49279	SUPPL	2017-08-08
49269	SUPPL	2017-08-08
36641	SUPPL	2014-05-02
27462	SUPPL	2014-05-01
15171	SUPPL	2012-12-28
5010	SUPPL	2012-12-27
27461	SUPPL	2012-11-05
15172	SUPPL	2012-11-02
27460	SUPPL	2012-05-02
15170	SUPPL	2012-04-27
42094	SUPPL	2007-07-09
42095	SUPPL	2007-04-30
5009	SUPPL	2007-02-12
36640	SUPPL	2004-07-21
27459	SUPPL	2004-07-21
5006	SUPPL	2004-05-28
36639	SUPPL	2003-09-30
5008	SUPPL	2003-09-30
5007	SUPPL	2003-08-28
21594	ORIG	2003-04-30
15169	SUPPL	2002-09-11
36638	ORIG	2002-06-26
5005	ORIG	2002-06-26