Application 079051
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NISOLDIPINE | NISOLDIPINE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | NISOLDIPINE | NISOLDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | Yes |
| 003 | NISOLDIPINE | NISOLDIPINE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079051-001 | NISOLDIPINE | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | ||
| A079051-002 | NISOLDIPINE | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | ||
| A079051-003 | NISOLDIPINE | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 |
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 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| nisoldipine | NISOLDIPINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | a52b773a-44f9-442f-a4be-39f79a558bd2 | 2026-06-08 | Warnings, Adverse reactions | nisoldipine NISOLDIPINE |
| Sular | NISOLDIPINE | Covis Pharma US, Inc | 589157fa-d129-4de3-be3d-e0e1c22c5873 | 2026-03-12 | Warnings, Adverse reactions | NISOLDIPINE |
| Nisoldipine | NISOLDIPINE | Prasco Laboratories | 8a5fb6a2-9fae-4872-8c5c-0f1ba03a57cb | 2021-10-01 | Warnings, Adverse reactions | Nisoldipine NISOLDIPINE |
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 |
|---|---|---|---|---|---|
| 0378-2222 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2222 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2222 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2223 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2223 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2223 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2224 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2224 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2224 | Nisoldipine | Nisoldipine | Mylan Pharmaceuticals Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31406 | ORIG | 2008-07-31 |