Application 020356
- Type
- NDA
- Sponsor
- COVIS PHARMA BV
Application Products#
| 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| TABLET, EXTENDED RELEASE;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TABLET, EXTENDED RELEASE;ORAL | 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
Orange Book products#
| 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| N020356-001 | SULAR | NISOLDIPINE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1995-02-02 | |
| N020356-002 | SULAR | NISOLDIPINE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1995-02-02 | |
| N020356-003 | SULAR | NISOLDIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1995-02-02 | |
| N020356-004 | SULAR | NISOLDIPINE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1995-02-02 | |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#
| 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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020356-008 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020356-008 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020356-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020356-007 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020356-008 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020356-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020356-007 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020356-008 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020356-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020356-007 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020356-008 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020356-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020356-007 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020356-008 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020356-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020356-007 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020356-008 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020356-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020356-007 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020356-008 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020356-005 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020356-007 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020356-008 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020356-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020356-007 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020356-008 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020356-005 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020356-007 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020356-008 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020356-005 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020356-007 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020356-008 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020356-005 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020356-007 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020356-008 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020356-005 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020356-007 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020356-008 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020356-005 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020356-007 | AB | 1 | 1e350fbaab3a… |
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.
| 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 | 020356 NDA020356 70515-503 70515-501 70515-500 |
| Nisoldipine | NISOLDIPINE | Prasco Laboratories | 8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb | 2021-10-01 | Warnings, Adverse reactions | 020356 NDA020356 66993-472 66993-473 66993-475 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| 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 |