Application 205629
- Type
- ANDA
- Sponsor
- OSMOTICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 8MG | No | No |
| 002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 12MG | No | No |
| 003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 16MG | No | No |
| 004 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 32MG | No | Yes |
| 005 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 24MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205629-001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | |
| A205629-002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | |
| A205629-003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | |
| A205629-004 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 |
| A205629-005 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205629-001 | AB |
| A205629-002 | AB |
| A205629-003 | AB |
| A205629-004 | AB |
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 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-005 | HYDROMORPHONE HYDROCHLORIDE | 24MG | TABLET, EXTENDED RELEASE / ORAL | 2024-10-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-002 | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-003 | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-004 | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2016-07-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205629-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2016-07-07 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205629-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205629-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205629-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205629-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205629-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205629-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205629-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205629-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205629-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205629-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205629-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205629-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205629-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205629-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205629-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205629-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205629-004 | AB | 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 |
|---|---|---|---|---|---|---|
| Hydromorphone Hydrochloride | HYDROMORPHONE HYDROCHLORIDE | Trigen Laboratories, LLC | 8bb81796-6990-40e9-bee4-1f292f91ae99 | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | 205629 ANDA205629 13811-702 13811-701 13811-703 13811-704 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13811-701 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-701 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-701 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-701 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-701 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-702 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-702 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-702 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-702 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-702 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-703 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-703 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-703 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-703 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-703 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-704 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-704 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-704 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-704 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |
| 13811-704 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Trigen Laboratories, LLC | ANDA | Current |