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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021044-001 | PALLADONE | 12MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021044-002 | PALLADONE | 16MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021044-003 | PALLADONE | 24MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021044-004 | PALLADONE | 32MG | CAPSULE, EXTENDED RELEASE / ORAL | 2004-09-24 | 4b0b4de00fa7… |
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 | Redpharm Drug | 59d88866-e1ba-9d97-e063-6394a90a7b27 | 2026-08-25 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 67e79859-4efc-4ea7-8211-cadf746bc864 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 31d5a37a-0e90-4e88-be14-75c877be9de2 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Dilaudid | HYDROMORPHONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 9eebd88a-5632-460f-b7b6-26c8a180540d | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | e034eb96-03e0-46e1-8b92-5e1f94555e7b | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | SpecGx LLC | 4c5c1cc8-c42b-46e3-ad68-8e22f57101f2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Bryant Ranch Prepack | 2427814c-f32b-8ac5-99b8-5e886fd2d001 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 53ddcacc-99e4-8b21-e063-6394a90a3e79 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Dilaudid | HYDROMORPHONE HYDROCHLORIDE | Rhodes Pharmaceuticals LLC | d6b40e39-a57e-402c-b4f6-7041e832f837 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Teva Parenteral Medicines, Inc. | f0b78db9-a38c-41bb-8233-5e93f7f18c5c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Rhodes Pharmaceuticals LLC | 37565441-0d95-4743-a695-d7b3326f58a1 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | American Health Packaging | fab97112-e276-40e0-bc82-0a29d7fa75fa | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hospira, Inc. | 3832ede8-d3fc-455d-ecab-3b77be5869f5 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Bryant Ranch Prepack | c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | b325028e-0722-4c8c-9fdb-ab6fb0dc460c | 2026-03-02 | Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | American Health Packaging | e4758743-9b2c-4612-8399-ad2db372e2b7 | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | cc574063-6ede-4da7-82c4-7450c92b229b | 2026-02-27 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hospira, Inc. | f9ca2ef5-46d8-475a-a26e-f7c8becd6db7 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | c729424e-e483-4bf8-b86c-ce56636dcffa | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Hospira, Inc. | e9c9ef18-7dfc-4322-b2fc-29b934c30f8b | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | HYDROMORPHONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.