Application 210758
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 5MG/5ML | No | No |
| 002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | SOLUTION;ORAL | 100MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210758-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | |
| A210758-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210758-001 | AA |
| A210758-002 | 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 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210758-001 | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A210758-002 | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION / ORAL | AA | 2018-04-30 | 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 | A210758-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210758-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210758-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210758-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210758-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210758-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210758-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210758-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210758-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210758-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210758-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210758-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210758-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210758-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210758-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210758-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210758-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210758-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210758-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210758-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210758-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210758-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210758-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210758-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210758-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210758-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210758-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210758-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210758-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A210758-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A210758-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A210758-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210758-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A210758-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A210758-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A210758-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A210758-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A210758-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A210758-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A210758-002 | AA | 1 | 74a2ff9319b5… |
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 | Strides Pharma Science Limited | f3116ebf-d72c-4e98-aa50-006be4770c86 | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXAYDO | OXYCODONE HYDROCHLORIDE | Zyla Life Sciences US LLC | cff0c64a-63f5-4b3c-909a-cdecf6755cbe | 2026-01-04 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE |
| Oxycodone hydrochloride | OXYCODONE HYDROCHLORIDE | Alvogen, Inc. | 20bb6bb4-230a-c9c2-01d8-a6e9341e96ba | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | 056bdaac-4a43-42f0-9435-f349d3ccc128 | 2025-12-27 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Aurolife Pharma, LLC | 96ad4352-fff3-46a7-85de-466cc161045e | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 3745020d-df8c-7209-e063-6394a90aabd7 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Redpharm Drug | 439c2de6-3ea5-e829-e063-6294a90aa77d | 2025-12-02 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 73b063b5-24b7-40bf-bc2a-c0e1bfaf61d1 | 2025-11-28 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | American Health Packaging | aa7ac2bf-d9ed-445d-b394-4d3fe39780ca | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 08977126-9671-4d87-9724-1599ca86e181 | 2025-10-16 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3cd01fb7-b59c-fc5d-e063-6394a90a21d2 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 3ca9f0d9-a40d-4416-e063-6394a90aec8b | 2025-08-18 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | DIRECT RX | a8206207-ad09-83df-e053-2995a90a78b7 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | RedPharm Drug, Inc. | 92614a3a-331d-16ad-e053-2a95a90a47cc | 2025-04-09 | Boxed warning, Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | American Health Packaging | 0a6b0659-6816-4f44-81bd-9bac4da5380d | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | e2e52a0e-a80b-4225-b034-37a62f839d92 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Asclemed USA, Inc. | c10cc127-8756-4ddc-9f46-1e003ef271dc | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | Quality Care Products LLC | 4cadb809-157d-49cc-97b4-3276594f19d2 | 2024-12-19 | Warnings, Adverse reactions | OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Precision Dose, Inc. | f849c7cc-fa85-47eb-be30-1be137913bf9 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | d9841f2d-d182-4888-9a3c-68e1afb3e19c | 2024-11-20 | Boxed warning, Warnings, Adverse reactions | Oxycodone Hydrochloride OXYCODONE HYDROCHLORIDE |
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 |
|---|---|---|---|---|---|
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8556 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
| 0406-8557 | Oxycodone Hydrochloride | Oxycodone Hydrochloride | SpecGx LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 76435 | ORIG | 2023-11-07 |