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HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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HYDROCHLORIDE | INJECTABLE;INJECTION | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | |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| CARDIZEM | DILTIAZEM HYDROCHLORIDE | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 |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| 2026-08 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | 84e616aacf4f… | |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| 2026-08 | N020027-003 | CARDIZEM | 25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-18 | 84e616aacf4f… | |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| 2026-07 | N020027-001 | CARDIZEM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1991-10-24 | caaa826d4ba7… | |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 Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 762c3007-b22f-4d35-87b4-191fec8b3a9a | 2023-11-20 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride Extended-Release | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | eed8cfeb-6ec7-4914-b8e0-a5c3d623c9a4 | 2023-11-20 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | eebf29fe-ce22-4482-b850-5854550bf2c4 | 2023-08-04 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 225a87fb-d353-4ee7-bd08-14d631ff6b16 | 2023-06-07 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 9f69371d-3ede-285d-e053-2a95a90a6e42 | 2023-05-30 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Proficient Rx LP | a24255a3-88b1-47ef-90fc-51619a1c5a63 | 2023-05-01 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem hydrochloride | DILTIAZEM HYDROCHLORIDE | A-S Medication Solutions | 5460158f-7782-45f4-89b1-f84e6ba178d8 | 2023-01-17 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 6f71ba5e-7bd6-409a-80c6-2f22d975aefc | 2023-01-09 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Oceanside Pharmaceuticals | f6a24de7-8ffe-48af-873f-10fdcd5551d1 | 2020-06-02 | Warnings, Adverse reactions | DILTIAZEM HYDROCHLORIDE |
| Diltiazem Hydrochloride | DILTIAZEM HYDROCHLORIDE | Bryant Ranch Prepack | 609e97e5-ebc7-4268-84ea-f279284c89e2 | 2020-01-19 | 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 |