Application 020356

Type: NDA
Sponsor: COVIS PHARMA BV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	34MG	Yes	Yes
006	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	17MG	Yes	Yes
008	SULAR	NISOLDIPINE	TABLET, EXTENDED RELEASE;ORAL	8.5MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020356-001	SULAR	NISOLDIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-002	SULAR	NISOLDIPINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-003	SULAR	NISOLDIPINE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-004	SULAR	NISOLDIPINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02
N020356-005	SULAR	NISOLDIPINE	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-006	SULAR	NISOLDIPINE	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-007	SULAR	NISOLDIPINE	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02
N020356-008	SULAR	NISOLDIPINE	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020356-008	AB

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 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020356-001	SULAR	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-002	SULAR	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-003	SULAR	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-004	SULAR	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1995-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-005	SULAR	34MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-006	SULAR	25.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-007	SULAR	17MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020356-008	SULAR	8.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-01-02	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N020356-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020356-007	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020356-008	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020356-005	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020356-007	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020356-008	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020356-005	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020356-007	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020356-008	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020356-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020356-007	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020356-008	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020356-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020356-007	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020356-008	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020356-005	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020356-007	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020356-008	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020356-005	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020356-007	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020356-008	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020356-005	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020356-007	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020356-008	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020356-005	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020356-007	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020356-008	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020356-005	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020356-007	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020356-008	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020356-005	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020356-007	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020356-008	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020356-005	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020356-007	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020356-008	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020356-005	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020356-007	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020356-008	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020356-005	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sular	NISOLDIPINE	Covis Pharma US, Inc	589157fa-d129-4de3-be3d-e0e1c22c5873	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020356 application number: NDA020356 ndc (product): 70515-503 ndc (product): 70515-501 ndc (product): 70515-500
Nisoldipine	NISOLDIPINE	Prasco Laboratories	8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb	2021-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020356 application number: NDA020356 ndc (product): 66993-472 ndc (product): 66993-473 ndc (product): 66993-475

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0677-1978	Nisoldipine	Nisoldipine	United Research Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current
0677-1979	Nisoldipine	Nisoldipine	United Research Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current
0677-1980	Nisoldipine	Nisoldipine	United Research Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current
0677-1981	Nisoldipine	Nisoldipine	United Research Laboratories, Inc.	NDA AUTHORIZED GENERIC	Current
59630-500	SULAR	Nisoldipine	Shionogi Inc.	NDA	Current
59630-501	SULAR	Nisoldipine	Shionogi Inc.	NDA	Current
59630-503	SULAR	Nisoldipine	Shionogi Inc.	NDA	Current
66993-472	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-472	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-473	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-473	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-475	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-475	Nisoldipine	Nisoldipine	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
70515-500	Sular	nisoldipine	Covis Pharma	NDA	Current
70515-500	Sular	nisoldipine	Covis Pharma US, Inc	NDA	Current
70515-500	Sular	nisoldipine	Covis Pharma	NDA	Current
70515-501	Sular	nisoldipine	Covis Pharma	NDA	Current
70515-501	Sular	nisoldipine	Covis Pharma US, Inc	NDA	Current
70515-501	Sular	nisoldipine	Covis Pharma	NDA	Current
70515-503	Sular	nisoldipine	Covis Pharma	NDA	Current
70515-503	Sular	nisoldipine	Covis Pharma US, Inc	NDA	Current
70515-503	Sular	nisoldipine	Covis Pharma	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
48749	ORIG	2017-06-16
48713	SUPPL	2017-06-14
20603	SUPPL	2012-02-28
24813	SUPPL	2008-01-09
41289	SUPPL	2001-06-04
20602	SUPPL	2001-06-04
57428	ORIG	1995-02-02