Application 086242
- Type
- ANDA
- Sponsor
- HERITAGE PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A086242-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | ||
| A086242-002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | ||
| A086242-003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | ||
| A086242-004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 |
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 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2010-02-04 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2010-02-04 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-002 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-003 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-04 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A086242-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A086242-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A086242-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A086242-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A086242-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A086242-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A086242-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A086242-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A086242-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A086242-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A086242-004 | AA | 1 | d06236e962d9… |
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | a04eefaf-ba3c-448d-8ece-4aa9ab2e3508 | 2026-01-09 | Warnings, Adverse reactions | 086242 ANDA086242 |
| HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e9450e82-329f-4fd8-a0b3-3e8e22715965 | 2026-01-07 | Warnings, Adverse reactions | 086242 ANDA086242 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Chartwell RX, LLC | 0c7f9bd0-6c0a-4521-b77a-3582faa96874 | 2025-12-10 | Warnings, Adverse reactions | 086242 ANDA086242 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 63f388e0-9f3d-4902-990c-9a105aa098ad | 2020-09-01 | Warnings, Adverse reactions | 086242 ANDA086242 63187-901 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55154-7294 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7294 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7294 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7295 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Cardinal Health | ANDA | Current |
| 55289-133 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-312 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-312 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-846 | HYDRALAZINE HCL | HYDRALAZINE HCL | DirectRX | ANDA | Current |
| 62584-733 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-733 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-733 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-733 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-734 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-734 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-734 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 62584-734 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 63187-901 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-901 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-901 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-5696 | Hydralazine Hydrochloride | hydralazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5696 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-5696 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66267-676 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-676 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-270 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-280 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-3279 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3279 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3279 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4490 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68084-447 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-447 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-447 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-447 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | American Health Packaging | ANDA | Current |
| 68788-6917 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Preferred Pharmaceuticals Inc | ANDA | Current |
| 68788-7330 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7330 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7330 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0479 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0479 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0666 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0832 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1685 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
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| 71335-0482 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0482 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
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| 71335-0594 | HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0594 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
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