Application 040050
- Type
- ANDA
- Sponsor
- SPECGX LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHADOSE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | METHADOSE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040050-001 | METHADOSE | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 1993-04-15 | ||
| A040050-002 | METHADOSE | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 1993-04-15 |
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 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | 1993-04-15 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | 1993-04-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040050-001 | METHADOSE | 5MG | TABLET / ORAL | AA | 1993-04-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040050-002 | METHADOSE | 10MG | TABLET / ORAL | AA | 1993-04-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A040050-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040050-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A040050-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040050-002 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040050-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040050-002 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040050-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040050-002 | AA | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | American Health Packaging | 540edd43-165d-4257-b989-3bccc8f54afb | 2026-09-09 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADOSE DISPERSIBLE | METHADONE HYDROCHLORIDE | SpecGx LLC | 544483e6-6f9d-4371-9e93-313e54e0ea05 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | SpecGx LLC | 14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab58 | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Major Pharmaceuticals | db52fdc0-765a-4fad-a8f9-ef98c6e4b898 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP. | d7b30c78-c531-4dc5-9552-d68daa3210d1 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Long Grove Pharmaceuticals, LLC | f453f1b9-d46e-4be8-835d-dbeb9d98a149 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Breckenridge Pharmaceutical Inc | 13541167-95f4-4cb9-9d7d-3c1aced5c5f6 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | 5baef1bf-8bf0-429c-a4ce-1c93171f3f15 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SpecGx LLC | eddf7077-02fb-4771-9823-31984f4ff2bb | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADOSE | METHADONE HYDROCHLORIDE | SpecGx LLC | 808a9d0b-720b-4034-a862-5122ff514608 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | METHADOSE METHADONE HYDROCHLORIDE |
| Methadone Hydrocloride dye-free, sugar-free, unflavored | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | 714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Ascend Laboratories, LLC | f0366917-f745-4b01-a662-a98a7d80b4a0 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrocloride dye-free, sugar-free, unflavored | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | f9dad5d5-3417-4992-99ee-6550f81add6b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | VistaPharm, LLC | 7ff89589-149c-4007-8144-5f60131b8c33 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d0e6a966-179a-45e0-8444-4c1b8523f8d2 | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA | e72841bf-364b-49b1-8e69-7e26ddcd2657 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | VistaPharm, LLC | d5bd3e97-b3f6-4bc2-9fb7-02921be35cdb | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | VistaPharm, LLC | c54baaee-8ea4-45f5-a5c8-bb84cf86832f | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrocloride dye-free, sugar-free, unflavored | METHADONE HYDROCHLORIDE | Lannett Company, Inc. | 0955ea4a-c6b8-431f-ba42-9641b5b102ea | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Mylan Institutional LLC | 092d78eb-6423-495c-bf0d-e6532bea7138 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.