Application 078458
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | |
| A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | |
| A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | |
| A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2016-06-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078458-001 | AB1 |
| A078458-002 | AB1 |
| A078458-003 | AB1 |
| A078458-004 | AB1 |
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 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | 2011-12-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-004 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RS | 2016-06-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078458-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078458-004 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078458-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078458-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078458-004 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078458-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078458-004 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078458-004 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-003 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078458-004 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-003 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078458-004 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-002 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-003 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078458-004 | AB1 | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Methylphenidate Hydrochloride (LA) | METHYLPHENIDATE HYDROCHLORIDE | Mayne Pharma | e5db854a-1c77-4faf-9e60-daf9c9b6cfa0 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 078458 ANDA078458 51862-612 51862-611 51862-610 51862-614 |
| Methylphenidate Hydrochloride (LA) | METHYLPHENIDATE HYDROCHLORIDE | Dr. Reddy's Laboratories Inc | d8c14df4-ac05-d69d-9308-58a51d568329 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 078458 ANDA078458 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3230 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3230 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3231 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3231 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3232 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3232 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 51862-263 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-263 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-264 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-264 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-265 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-265 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-267 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-610 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-610 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-610 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-610 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-611 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-611 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-611 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-611 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-612 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-612 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-612 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-612 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |
| 51862-614 | Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | Mayne Pharma | ANDA | Current |