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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | A079051-003 | NISOLDIPINE | 40MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A079051-001 | NISOLDIPINE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2008-07-25 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A079051-002 | NISOLDIPINE | 30MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2008-07-25 | c0c555d07b60… |
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 |