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| CAPSULE, EXTENDED RELEASE;ORAL | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CAPSULE, EXTENDED RELEASE;ORAL | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 | |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| CARDIZEM SR | DILTIAZEM HYDROCHLORIDE | 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1989-01-23 |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 | Ingenus Pharmaceuticals, LLC | 355f560a-8ebb-4661-ad74-2a22f707d7f8 | 2025-06-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| TIADYLT ER | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | b4b4e53e-fc99-4f34-abc2-57e4f28aff84 | 2025-06-13 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | c044f774-783f-4920-a8a1-6d4b1b3820c1 | 2025-06-11 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Cartia XT | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | de671934-25a8-4df6-b7a1-97e0337e9e2b | 2025-06-02 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 69ca7cae-fdf3-413a-900b-95cf6e9e7b63 | 2025-05-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 976d9dd0-4f11-4439-b84e-0c0f0e018d8b | 2025-05-22 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Viona Pharmaceuticals Inc | 43cffe12-304a-4e15-9512-94f812188f1a | 2025-05-05 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| TIADYLT ER | DILTIAZEM HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 1278cd76-b8e9-42d9-ad19-6858e72cf9f2 | 2025-05-02 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| TIADYLT ER | DILTIAZEM HYDROCHLORIDE | Zydus Lifesciences Limited | d88e3546-3984-4dc9-893a-a29e95804550 | 2025-05-02 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Coupler LLC | 3418eb02-117e-a71a-e063-6394a90a826e | 2025-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 1e2f2025-0350-40c4-ab42-3b57f3d105a6 | 2025-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Actavis Pharma, Inc. | 178eec1f-1d4d-4a38-b66a-d3ba3de06c3d | 2025-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | Zydus Lifesciences Limited | fe790439-85d4-4cd8-a385-149ea3442a38 | 2025-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Cardizem | DILTIAZEM HYDROCHLORIDE | Bausch Health US LLC | f3e7ecef-f360-4987-a4f5-933214130ab2 | 2025-04-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Ingenus Pharmaceuticals, LLC | 64401d2a-bd5b-43fd-879a-e9d16345e827 | 2025-04-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | AvKARE | 31e63a95-9e62-01c8-e063-6294a90af0e1 | 2025-04-03 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Cartia XT | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | e02f5fad-6482-4d5d-91c5-0ae6b0ce15b8 | 2025-03-06 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Coupler LLC | 2ced821f-19a6-4c7e-e063-6394a90adb80 | 2025-01-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Coupler LLC | 2cd92b83-075e-b069-e063-6294a90a9fff | 2025-01-29 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| CARTIA XT | DILTIAZEM HYDROCHLORIDE | DirectRx | dbfda3a5-5602-6e47-e053-2995a90ac07b | 2025-01-22 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.