Application 200792
- Type
- ANDA
- Sponsor
- PAR PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 7.5MG | No | No |
| 003 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 004 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 005 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 006 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 007 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200792-001 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-002 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-003 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-004 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-005 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-006 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | ||
| A200792-007 | OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-004 | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-005 | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-006 | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200792-007 | OXYMORPHONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200792-001 | OXYMORPHONE HYDROCHLORIDE | 5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200792-002 | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200792-003 | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE / ORAL | 2014-10-24 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Oxymorphone Hydrochloride | OXYMORPHONE HYDROCHLORIDE | Aurolife Pharma, LLC | 22c7652a-aa16-4fa8-89d9-517e69059068 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | Oxymorphone Hydrochloride OXYMORPHONE HYDROCHLORIDE |
| Oxymorphone Hydrochloride | OXYMORPHONE HYDROCHLORIDE | KVK-Tech, Inc. | dcb5b5d2-7d0a-497a-8f1e-3b96fd43320b | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | Oxymorphone Hydrochloride OXYMORPHONE HYDROCHLORIDE |
| Oxymorphone hydrochloride | OXYMORPHONE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 3f4e703a-e398-42fd-8759-e398c79955f1 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Oxymorphone hydrochloride OXYMORPHONE HYDROCHLORIDE |
| Oxymorphone Hydrochloride | OXYMORPHONE HYDROCHLORIDE | Epic Pharma, LLC | 95804e72-232d-425d-b23d-a66f43bdf0c6 | 2025-12-15 | Boxed warning, Warnings, Adverse reactions | Oxymorphone Hydrochloride OXYMORPHONE HYDROCHLORIDE |
| Oxymorphone Hydrochloride | OXYMORPHONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 3eb971cf-ab82-49f3-a46c-4d76a8ce599e | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | Oxymorphone Hydrochloride OXYMORPHONE HYDROCHLORIDE |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | Camber Pharmaceuticals, Inc | 06af7dff-c261-4c03-9cd9-0605c42507fa | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE |
| Oxymorphone hydrochloride | OXYMORPHONE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 557e9610-62d7-42bf-90c1-44215bd8c1f8 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | Oxymorphone hydrochloride OXYMORPHONE HYDROCHLORIDE |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | Bryant Ranch Prepack | 560e9425-dfcb-4fb4-a759-b1e3f8f40fdb | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE |
| OXYMORPHONE HYDROCHLORIDE | OXYMORPHONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc. | 1a1d5061-b62a-49fa-a5b2-4970f51416ae | 2020-05-07 | Boxed warning, Warnings, Adverse reactions | OXYMORPHONE HYDROCHLORIDE OXYMORPHONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.