Application 021044
- Type
- NDA
- Sponsor
- PURDUE PHARMA LP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 12MG | No | No |
| 002 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 16MG | No | No |
| 003 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 24MG | No | No |
| 004 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 32MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021044-001 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | ||
| N021044-002 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | ||
| N021044-003 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | ||
| N021044-004 | PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 |
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 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021044-001 | 6589960 | 2020-11-09 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021044-002 | 6589960 | 2020-11-09 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021044-003 | 6589960 | 2020-11-09 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021044-004 | 6589960 | 2020-11-09 | Drug product | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021044-001 | 6589960 | 2020-11-09 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021044-002 | 6589960 | 2020-11-09 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021044-003 | 6589960 | 2020-11-09 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021044-004 | 6589960 | 2020-11-09 | Drug product | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021044-001 | 6589960 | 2020-11-09 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021044-002 | 6589960 | 2020-11-09 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021044-003 | 6589960 | 2020-11-09 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021044-004 | 6589960 | 2020-11-09 | Drug product | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021044-001 | 6589960 | 2020-11-09 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021044-002 | 6589960 | 2020-11-09 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021044-003 | 6589960 | 2020-11-09 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021044-004 | 6589960 | 2020-11-09 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021044-001 | 6589960 | 2020-11-09 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021044-002 | 6589960 | 2020-11-09 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021044-003 | 6589960 | 2020-11-09 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021044-004 | 6589960 | 2020-11-09 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021044-001 | 6589960 | 2020-11-09 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021044-002 | 6589960 | 2020-11-09 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021044-003 | 6589960 | 2020-11-09 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021044-004 | 6589960 | 2020-11-09 | Drug product | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Trigen Laboratories, LLC | 8bb81796-6990-40e9-bee4-1f292f91ae99 | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| hydromorphone hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Padagis US LLC | 780a2616-0392-4715-bc50-71799bea1957 | 2025-12-22 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | ASCLEMED USA INC. | 18f6f54e-1537-4181-9d07-54ddf881a9ee | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| hydromorphone hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | c33e6320-4206-4b69-8cac-ebfc2351b8f2 | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | Ascent Pharmaceuticals Inc | 4de15afe-d676-4faa-a34d-9b9cb20dbf54 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | Bryant Ranch Prepack | 29765ff0-3b1d-47da-953e-28bf0e6a56ef | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| hydromorphone hydrochloride | HYDROMORPHONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc. | 90bda45c-9dbe-4ed5-91d0-df8446ad7026 | 2024-01-17 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | Bryant Ranch Prepack | bec32a94-4b79-4bd4-b000-45e9030d3106 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | Aurolife Pharma, LLC | f778dfab-e109-428e-b1b7-4dfb1b8293e4 | 2023-12-25 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | Padagis US LLC | 1bfbba46-1979-4797-a29e-d67718131686 | 2023-09-01 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Ascent Pharmaceuticals Inc | e8fd7b0e-22b9-4f8a-8eb2-41d5031779af | 2017-05-03 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.