Application 020027
- Type
- NDA
- Sponsor
- BIOVAIL LABS INTL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020027-001 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | |
| N020027-003 | CARDIZEM | DILTIAZEM HYDROCHLORIDE | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 |
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| 2026-08 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020027-001 | CARDIZEM | 5MG/ML | INJECTABLE / INJECTION | RLD | 1991-10-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020027-001 | CARDIZEM | 5MG/ML | INJECTABLE / INJECTION | RLD | 1991-10-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 74a2ff9319b5… |
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 | Cardizem 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.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 1913 | SUPPL | 2004-12-30 |