Application 077471
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 8MG | No | No |
| 002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 2MG | No | No |
| 003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | TABLET;ORAL | 4MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077471-001 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | ||
| A077471-002 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | ||
| A077471-003 | HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 |
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 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077471-002 | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET / ORAL | 2009-12-09 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077471-003 | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET / ORAL | 2009-12-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077471-001 | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET / ORAL | 2009-12-09 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077471-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077471-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077471-003 | AB | 1 | 74a2ff9319b5… |
| 2021-03-12 10:30 UTC | 2021-03 | A077471-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077471-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A077471-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077471-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077471-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A077471-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077471-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077471-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A077471-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077471-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077471-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077471-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077471-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077471-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077471-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077471-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077471-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077471-003 | AB | 1 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1353 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1353 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1353 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1354 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1354 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1354 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1355 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1355 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1355 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 35356-814 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-814 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-814 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 52959-413 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 63739-275 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | McKesson Corporation | ANDA | Current |
| 63739-791 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | McKesson Corporation | ANDA | Current |
| 67296-1642 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1642 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68084-423 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-423 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-423 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-472 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-472 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 68084-472 | HYDROmorphone Hydrochloride | HYDROmorphone Hydrochloride | American Health Packaging | ANDA | Current |
| 71335-0233 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0233 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0265 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0265 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0303 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0303 | Hydromorphone Hydrochloride | Hydromorphone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76081 | ORIG | 2023-11-02 |