Application 040858
- 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 | 25MG | No | No |
| 003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| A040858-001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | |
| A040858-002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | |
| A040858-003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | |
| A040858-004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040858-001 | AA |
| A040858-002 | AA |
| A040858-003 | AA |
| A040858-004 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-001 | HYDRALAZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2010-02-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-002 | HYDRALAZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | 2010-02-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-003 | HYDRALAZINE HYDROCHLORIDE | 50MG | TABLET / ORAL | AA | 2010-02-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-004 | HYDRALAZINE HYDROCHLORIDE | 100MG | TABLET / ORAL | AA | 2010-02-26 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040858-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040858-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040858-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040858-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040858-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040858-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040858-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040858-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040858-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040858-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040858-004 | 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 | Major Pharmaceuticals | b6ccd35e-f69c-4eef-a456-905e030ae911 | 2026-07-15 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 1275dd50-d97f-2e8f-e063-6394a90a4a67 | 2026-06-22 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | d61ffa06-8138-4a1d-9530-095a80d9c9ce | 2026-06-12 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | a70d20d6-23f0-477e-915c-678a86782175 | 2026-06-12 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | a1066707-2391-4918-8ded-600c017fde48 | 2026-05-18 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 669532c9-ba15-4f4b-95a8-13782deb3521 | 2026-04-03 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 6c40d818-77a9-492c-b9b6-d8a0fe8d6736 | 2026-03-09 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | 336b11da-e592-4386-921f-3c136d754f2a | 2025-11-06 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Proficient Rx LP | 024ac6b8-5ce0-4435-9b11-b1806c511d7b | 2025-07-01 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 51c293c1-70e7-48c7-8af1-a8b74312ed56 | 2025-06-19 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | Coupler LLC | 2e9688ef-781c-aead-e063-6294a90a7bca | 2025-02-20 | Warnings, Adverse reactions | 040858 ANDA040858 |
| Hydralazine Hydrochloride | HYDRALAZINE HYDROCHLORIDE | American Health Packaging | 2e82655e-8435-46fa-b734-8e7c6e803453 | 2024-09-23 | Warnings, Adverse reactions | 040858 ANDA040858 |