Application 084301
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DRALZINE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084301-001 | DRALZINE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 |
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 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A084301-001 | DRALZINE | 25MG | TABLET / ORAL | Approved before 1982 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 5da36930-d3da-4b5c-9e22-2b141bc01a9c | 2025-03-13 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Baxter Healthcare Corporation | f1a10203-f027-4f9c-8dd6-907c6db24d47 | 2025-03-10 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2e9688ef-781c-aead-e063-6294a90a7bca | 2025-02-20 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2df51a19-a39a-0ec8-e063-6394a90a147c | 2025-02-12 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 775e99c4-e18d-4648-a0e3-8709950249ff | 2025-02-01 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 94530e4d-b1c0-6171-e053-2a95a90a05fa | 2025-01-08 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 7ae650f7-a481-4637-a9a2-9bda43a5a288 | 2024-12-24 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | a862321d-ebc1-7676-e053-2995a90a5861 | 2024-12-17 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | ff2c4d1e-33ee-40d7-955b-d736f0559f39 | 2024-12-03 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 10f3e76e-9bba-4151-89fb-90d823a0a68c | 2024-11-08 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | American Health Packaging | 2e82655e-8435-46fa-b734-8e7c6e803453 | 2024-09-23 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Macleods Pharmaceuticals Limited | f9f56326-6d72-47d3-89ac-3625b8a6d713 | 2024-09-06 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | f07abdec-6d94-45b6-be1b-10a898ea28c2 | 2024-08-12 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | 8ade1ffe-3738-4aa1-b9c7-59f7290600b9 | 2024-08-07 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | A-S Medication Solutions | a8194ac4-02d5-4aa1-b4e4-a3759f6f64b5 | 2024-08-07 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3b61d1b0-c699-67a8-e054-00144ff88e88 | 2024-07-16 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4b7d3378-86f8-0a5f-e054-00144ff8d46c | 2024-07-15 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | 37ba0233-ed75-498a-a067-6220da573653 | 2024-05-24 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Modavar Pharmaceuticals LLC | a456bc34-0c79-44f4-9119-50028a978f5f | 2024-05-14 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Civica, Inc. | ffa483a4-de2a-4d42-ad27-afacd37f28e4 | 2024-04-28 | Warnings, Adverse reactions | HYDRALAZINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.