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 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.

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