Application 200535
- Type
- NDA
- Sponsor
- GENUS LIFESCIENCES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 100MG/5ML | Yes | Yes |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N200535-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 |
| N200535-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N200535-001 | AA |
| N200535-002 | AA |
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 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N200535-001 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2010-10-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200535-002 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | RLD | 2013-08-22 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N200535-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N200535-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N200535-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N200535-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N200535-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N200535-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200535-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N200535-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N200535-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N200535-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200535-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N200535-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200535-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N200535-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N200535-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N200535-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N200535-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N200535-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N200535-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N200535-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N200535-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N200535-002 | AA | 1 | 74a2ff9319b5… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-001 | M-14 | 2024-07-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N200535-002 | M-14 | 2024-07-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-001 | M-14 | 2024-07-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N200535-002 | M-14 | 2024-07-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-001 | M-14 | 2024-07-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N200535-002 | M-14 | 2024-07-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-001 | M-14 | 2024-07-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N200535-002 | M-14 | 2024-07-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-001 | M-14 | 2024-07-21 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N200535-002 | M-14 | 2024-07-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-001 | M-14 | 2024-07-21 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N200535-002 | M-14 | 2024-07-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-001 | M-14 | 2024-07-21 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N200535-002 | M-14 | 2024-07-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-001 | M-14 | 2024-07-21 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N200535-002 | M-14 | 2024-07-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-001 | M-14 | 2024-07-21 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N200535-002 | M-14 | 2024-07-21 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200535-001 | M-14 | 2024-07-21 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N200535-002 | M-14 | 2024-07-21 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N200535-001 | M-14 | 2024-07-21 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N200535-002 | M-14 | 2024-07-21 | 1c564ffb4f44… |
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 |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Genus Lifesciences Inc. | 6869fec9-1837-4221-afd8-5cc6fadd025d | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | 200535 NDA200535 64950-354 64950-353 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 3745020d-df8c-7209-e063-6394a90aabd7 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 200535 NDA200535 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 48433-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Safecor Health, LLC | NDA AUTHORIZED GENERIC | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-353 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 64950-354 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Genus Lifesciences Inc. | NDA | Current |
| 68462-347 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | Glenmark Pharmaceuticals, Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84639 | SUPPL | 2026-01-05 |
| 84569 | SUPPL | 2025-12-29 |
| 80081 | SUPPL | 2024-11-04 |
| 78220 | SUPPL | 2024-04-23 |
| 78219 | SUPPL | 2024-04-23 |
| 78188 | SUPPL | 2024-04-22 |
| 77071 | SUPPL | 2023-12-19 |
| 76945 | SUPPL | 2023-12-18 |
| 76241 | ORIG | 2023-11-03 |
| 68173 | SUPPL | 2021-07-23 |
| 68172 | SUPPL | 2021-07-23 |
| 68160 | SUPPL | 2021-07-22 |
| 66572 | SUPPL | 2021-03-08 |
| 66528 | SUPPL | 2021-03-05 |
| 66526 | SUPPL | 2021-03-05 |
| 60450 | SUPPL | 2019-10-09 |
| 60397 | SUPPL | 2019-10-08 |
| 60396 | SUPPL | 2019-10-08 |
| 55710 | SUPPL | 2018-10-01 |
| 55709 | SUPPL | 2018-10-01 |
| 55586 | SUPPL | 2018-09-24 |
| 55585 | SUPPL | 2018-09-24 |
| 46414 | SUPPL | 2016-12-21 |
| 46326 | SUPPL | 2016-12-20 |
| 40027 | SUPPL | 2014-06-23 |
| 32034 | SUPPL | 2013-09-05 |
| 32033 | SUPPL | 2013-09-05 |
| 40026 | SUPPL | 2013-08-27 |
| 18964 | SUPPL | 2013-08-27 |
| 9828 | SUPPL | 2012-01-30 |
| 44823 | ORIG | 2011-02-24 |
| 43347 | ORIG | 2011-02-24 |
| 40025 | ORIG | 2010-10-29 |
| 32032 | ORIG | 2010-10-25 |
| 43941 | ORIG | 2010-10-21 |