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| CAPSULE, EXTENDED RELEASE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | 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 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | 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 | caaa826d4ba7… | |
| 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… |
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 | 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 |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | bb32d681-9a83-431e-9984-a5cee2c94852 | 2026-04-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 839af3af-4040-4cf4-8d4a-881a053514cc | 2026-03-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Macleods Pharmaceuticals Limited | 850566b1-0c8e-42bc-85fa-c8ee710f34ba | 2026-03-09 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | a469b24a-fbec-4a2d-8b4c-b62c2b2c66f6 | 2026-02-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 734beeef-3968-4137-af2c-276e8a9317df | 2026-02-09 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | e99e1446-9c85-478c-9e23-a5f4104bbd22 | 2026-02-06 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | GLENMARK PHARMACEUTICALS INC., USA | fb1606ea-1cff-46fd-b8e5-8135da76436c | 2026-01-29 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Northwind Health Company, LLC | 106b33e3-b199-e555-e063-6294a90a5af5 | 2026-01-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Northwind Health Company, LLC | 09a5d332-347b-e73d-e063-6294a90a67ed | 2026-01-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Northwind Health Company, LLC | f29febd6-5a27-eb83-e053-2a95a90a5b7d | 2026-01-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 090aa3a9-910e-4f96-b748-783109aa96e6 | 2025-12-12 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Cardizem CD | DILTIAZEM HYDROCHLORIDE | Bausch Health US LLC | 1042fa13-e6af-46b9-8008-6c941f0978b1 | 2025-12-10 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | ec7e93b8-666c-4d2f-8d08-07931e09f748 | 2025-11-27 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Alembic Pharmaceuticals Limited | 74bab197-f719-48c0-ac84-c0cf0087b45a | 2025-11-21 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Alembic Pharmaceuticals Inc. | ab38794a-914d-4bcd-9c6d-1578aa10041a | 2025-11-19 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| DILTIAZEM HYDROCHLORIDE | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 3a620125-898a-47ba-9000-4295c3a3ad72 | 2025-11-18 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.