Application 020198
- Type
- NDA
- Sponsor
- ALVOGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ADALAT CC | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | Yes | No |
| 002 | ADALAT CC | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | Yes | Yes |
| 003 | ADALAT CC | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020198-001 | ADALAT CC | NIFEDIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | |
| N020198-002 | ADALAT CC | NIFEDIPINE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | |
| N020198-003 | ADALAT CC | NIFEDIPINE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 |
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| 2026-08 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020198-003 | ADALAT CC | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020198-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020198-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N020198-003 | AB1 | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | N020198-001 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020198-002 | AB1 | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N020198-003 | AB1 | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020198-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020198-002 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N020198-003 | AB1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020198-001 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020198-002 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N020198-003 | AB1 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020198-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020198-002 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N020198-003 | AB1 | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Nifedipine | NIFEDIPINE | Alembic Pharmaceuticals Limited | 1486f187-0ec6-4c70-8991-02c1493912b4 | 2022-11-28 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Alembic Pharmaceuticals Inc. | 63f062f6-5669-434c-8ded-9801d8486dbf | 2022-11-23 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Proficient Rx LP | d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6 | 2022-03-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Proficient Rx LP | 838d6e8f-37b0-48d3-b701-c4fa32a87b85 | 2020-02-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Proficient Rx LP | 4b6418a8-600f-470e-adf1-56207bb25c38 | 2019-11-01 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Aphena Pharma Solutions - Tennessee, LLC | 09a04e5f-d3b0-4ee3-b12d-f74203262179 | 2019-06-06 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Aphena Pharma Solutions - Tennessee, LLC | 95a53fc5-852d-4892-af20-2aaece9399ba | 2018-09-13 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Aphena Pharma Solutions - Tennessee, LLC | 36b07283-fc0e-4a14-b78f-1d2ab80e7f31 | 2018-05-07 | Warnings, Adverse reactions | NIFEDIPINE |
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 |
|---|---|---|---|---|---|
| 47781-368 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-368 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-369 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-369 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-370 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 47781-370 | Nifedipine | nifedipine | Alvogen Inc. | NDA AUTHORIZED GENERIC | Current |
| 50090-0695 | Nifedipine | nifedipine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0697 | Nifedipine | nifedipine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 52427-494 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 52427-494 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 52427-495 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 52427-495 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 52427-496 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 52427-496 | Adalat CC | nifedipine | Almatica Pharma Inc. | NDA | Current |
| 67544-185 | Adalat CC | nifedipine | Aphena Pharma Solutions - Tennessee, LLC | NDA | Current |
| 70518-1773 | Nifedipine | nifedipine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1773 | Nifedipine | nifedipine | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |