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| N020198-001 | ADALAT CC | NIFEDIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | |
| N020198-002 | ADALAT CC | NIFEDIPINE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | |
| N020198-003 | ADALAT CC | NIFEDIPINE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 |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| 2026-08 | N020198-001 | ADALAT CC | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 84e616aacf4f… | |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| 2026-08 | N020198-002 | ADALAT CC | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE / ORAL | RLD | 1993-04-21 | 84e616aacf4f… | |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 | Preferred Pharmaceuticals Inc. | cda16a27-f029-40a6-a0e8-2bed0de71169 | 2026-08-04 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Preferred Pharmaceuticals, Inc. | 4ee466dc-5a4e-4c77-8e94-8b510cafd61b | 2026-08-04 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Major Pharmaceuticals | acb493a3-b8f2-41a9-8ab2-550d97c4592a | 2026-06-30 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | St. Mary's Medical Park Pharmacy | 1add684f-d082-72cc-e063-6394a90a1214 | 2026-06-29 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | St. Mary's Medical Park Pharmacy | 1ab8945b-bea5-9827-e063-6294a90af334 | 2026-06-17 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Golden State Medical Supply, Inc. | d9a501be-8523-3924-e053-2995a90a8569 | 2026-06-16 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Cardinal Health 107, LLC | c98ecf77-ae9a-438b-9bad-ffbed25d95bc | 2026-06-11 | Warnings, Adverse reactions | NIFEDIPINE |
| nifedipine | NIFEDIPINE | Bryant Ranch Prepack | d7475c68-6310-4b9a-81c1-9209a9ade75f | 2026-06-04 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | e1cd5011-b80e-4b1b-8729-56260b8b3c26 | 2026-05-15 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Coupler LLC | 518d39af-0be1-acbc-e063-6294a90a4ada | 2026-05-11 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Major Pharmaceuticals | 41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9 | 2026-04-30 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | REMEDYREPACK INC. | bddfd658-ac61-4ba2-a3fa-07acc35d368a | 2026-04-24 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 59724871-b495-4911-a86d-20069ec42edd | 2026-04-22 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Ingenus Pharmaceuticals, LLC | 4d02eba2-e964-4fa7-aaae-25949b5f0316 | 2026-04-15 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Cardinal Health 107, LLC | 472621b6-c2b7-4582-9ceb-7cead55ff247 | 2026-04-09 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Ingenus Pharmaceuticals, LLC | 4d3e11d2-d320-45d3-96c8-48322202b504 | 2026-03-30 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | cb9d013a-2303-4e1d-a539-8ff04d5ec91d | 2026-03-25 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 0b4e9bbc-4c16-4611-9ea2-903852804227 | 2026-03-19 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Bryant Ranch Prepack | 888b3fac-2f2f-42b8-92d1-d37b6ed225a5 | 2026-03-19 | Warnings, Adverse reactions | NIFEDIPINE |
| Nifedipine | NIFEDIPINE | Major Pharmaceuticals | b885b6b5-71c6-4799-8b23-5ee8c17938a0 | 2026-03-03 | 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 |