Application 006134
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 5MG | Yes | Yes |
| 004 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SYRUP;ORAL | 10MG/30ML | No | No |
| 010 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N006134-002 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N006134-004 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | ||
| N006134-010 | DOLOPHINE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N006134-004 | DOLOPHINE HYDROCHLORIDE | 10MG/30ML | SYRUP / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N006134-010 | DOLOPHINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N006134-002 | DOLOPHINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N006134-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N006134-010 | AA | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N006134-002 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N006134-010 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N006134-002 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N006134-010 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N006134-002 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N006134-010 | 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 | VistaPharm, LLC | 4c8b541c-33e8-4969-b258-af150808d46e | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Aurolife Pharma, LLC | 6984eb5a-57a3-4686-bc67-91bc3e7a531e | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Epic Pharma, LLC | 6da7501b-b881-4bc7-891a-74214a00a3ac | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Elite Laboratories, Inc. | d702d32b-98b1-412d-934c-1cd96af4b95a | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 8c363f90-c378-48ae-abbc-aeb25c9bf5cb | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| DISKETS | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | e6af84de-cbfc-4a3b-bd73-6bcf77337168 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Precision Dose, Inc. | cbc42334-8783-4572-b8da-8c7451d14077 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 50f14803-78c0-4d19-8b5d-9a9c17582ac1 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Camber Pharmaceuticals, Inc | 8f4cf84e-165c-489d-a668-0f715053f196 | 2025-08-28 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 1a6dbcb0-68f2-4f8b-94ee-baa2aa296293 | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrocloride dye-free, sugar-free, unflavored | METHADONE HYDROCHLORIDE | Atlantic Biologicals Corp. | 373c649e-798d-770e-e063-6294a90a6e47 | 2025-05-29 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | American Health Packaging | f935effe-e5b2-4bf7-bbde-6e80bb99076f | 2025-05-13 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Precision Dose, Inc. | e980d666-d74d-4358-a3b7-c6accb15eba6 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc | 1a536622-dda3-41af-ab08-28e7c1bc9300 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | METHADONE HYDROCHLORIDE |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | 7a8635fe-6183-4cda-9029-50e4e6dd5832 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | METHADONE 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 |
|---|---|---|---|---|---|
| 0054-4218 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4218 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4218 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4218 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4219 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4219 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4219 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4219 | DOLOPHINE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4570 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4570 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4570 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4570 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-4570 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-4571 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4571 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4571 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-4571 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-4571 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-8553 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8553 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8553 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8553 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-8553 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-8554 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8554 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8554 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0054-8554 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0054-8554 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 35356-834 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-834 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-834 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-834 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-834 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 35356-835 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 61919-670 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | DIRECT RX | NDA | Current |
| 61919-670 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Direct_Rx | NDA | Current |
| 61919-670 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Direct_Rx | NDA | Current |
| 61919-670 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Direct_Rx | NDA | Current |
| 71335-0119 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | NDA | Current |
| 71335-0119 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | NDA | Current |
| 71335-1106 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 67723 | SUPPL | 2021-06-07 |
| 67675 | SUPPL | 2021-06-03 |
| 67672 | SUPPL | 2021-06-03 |
| 60348 | SUPPL | 2019-10-08 |
| 60301 | SUPPL | 2019-10-08 |
| 60300 | SUPPL | 2019-10-08 |
| 55819 | SUPPL | 2018-10-05 |
| 55818 | SUPPL | 2018-10-05 |
| 55643 | SUPPL | 2018-09-28 |
| 55642 | SUPPL | 2018-09-28 |
| 52282 | SUPPL | 2018-02-02 |
| 52253 | SUPPL | 2018-02-01 |
| 48581 | SUPPL | 2017-05-31 |
| 46275 | SUPPL | 2016-12-20 |
| 46274 | SUPPL | 2016-12-20 |
| 46196 | SUPPL | 2016-12-19 |
| 46195 | SUPPL | 2016-12-19 |
| 45458 | SUPPL | 2016-10-04 |
| 28 | SUPPL | 2016-04-22 |
| 74 | SUPPL | 2015-06-29 |
| 10682 | SUPPL | 2015-04-07 |
| 75 | SUPPL | 2015-04-03 |
| 27 | SUPPL | 2014-08-20 |
| 26 | SUPPL | 2014-04-17 |
| 32939 | SUPPL | 2014-04-16 |
| 25 | SUPPL | 2013-04-16 |
| 10681 | SUPPL | 2012-07-12 |
| 44437 | ORIG | 2012-07-11 |
| 73 | SUPPL | 2012-07-11 |
| 72 | SUPPL | 2012-07-11 |
| 43994 | ORIG | 2009-08-12 |
| 24 | SUPPL | 2006-12-04 |
| 32938 | SUPPL | 2006-11-21 |
| 20008 | SUPPL | 2006-11-17 |