Application 019471
- Type
- NDA
- Sponsor
- BIOVAIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019471-001 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |
| N019471-002 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |
| N019471-003 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |
| N019471-004 | CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019471-001 | CARDIZEM SR | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019471-002 | CARDIZEM SR | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019471-003 | CARDIZEM SR | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019471-004 | CARDIZEM SR | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | NORTHSTAR RX LLC | 56616fc9-f3f7-8e0a-22c8-a6af106e6b1d | 2026-08-05 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | f7137458-0db3-7ecd-e053-6394a90a5f95 | 2026-08-05 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Slate Run Pharmaceuticals, LLC | e66665e8-22eb-f5cd-e053-2a95a90a72e4 | 2026-08-05 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | ec928ee5-0809-4ba5-82ca-ecfed99ebb5a | 2026-07-21 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Major Pharmaceuticals | e7476adc-a940-4e76-a1dd-c418de493bc0 | 2026-07-14 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | fb6a6199-bb70-476e-a2a2-b7594c9c001a | 2026-07-10 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | American Health Packaging | 11b43a17-8038-462b-8902-259431ad5256 | 2026-06-22 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 465dbab3-f201-4441-8f55-92a843b5134f | 2026-06-19 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Golden State Medical Supply, Inc. | c9f17187-e958-106b-e053-2a95a90a54d8 | 2026-06-16 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 50df9f09-aa2f-495d-a25c-7c5c0fdffcf0 | 2026-05-27 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Hospira, Inc. | bba03666-ff4f-4bf6-fa92-78e1ec2d9073 | 2026-05-24 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 76e04232-b3da-48e8-a944-5f4f97a508df | 2026-05-13 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | f276d9fe-a685-4d99-ad82-d4452ef4ba98 | 2026-05-08 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Northstar Rx LLC | e2511ffe-5821-4f64-a469-f8ef9618b1b5 | 2026-05-05 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Zydus Lifesciences Limited | 8329d0ac-d68c-48d2-9cbc-e1a1b60192d9 | 2026-05-01 | DILTIAZEM HYDROCHLORIDE | |
| Cartia XT | DILTIAZEM HYDROCHLORIDE | Actavis Pharma, Inc. | 2dc2b889-8443-4f7f-83be-86c68e179804 | 2026-04-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | 04a85be5-f746-418e-8e37-292703f16934 | 2026-04-29 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Cardinal Health 107, LLC | bdb9e7cf-bfbb-48b4-a8be-9038820d8279 | 2026-04-23 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | REMEDYREPACK INC. | 5e935265-d0fc-4223-835f-72426eeea6c4 | 2026-04-10 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 3d594530-885f-45c7-b8a5-fd7e503ff83f | 2026-04-06 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |