Application 205105
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 005 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 006 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 60MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | |
| A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205105-001 | AB2 |
| A205105-002 | AB2 |
| A205105-003 | AB2 |
| A205105-004 | AB2 |
| A205105-005 | AB2 |
| A205105-006 | AB2 |
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 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-005 | METHYLPHENIDATE HYDROCHLORIDE | 50MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-006 | METHYLPHENIDATE HYDROCHLORIDE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-001 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-002 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-003 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-004 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | AB2 | 2016-07-28 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205105-001 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-002 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-003 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-004 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-005 | AB2 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205105-006 | AB2 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-001 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-002 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-003 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-004 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-005 | AB2 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205105-006 | AB2 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-001 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-002 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-003 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-004 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-005 | AB2 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205105-006 | AB2 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-001 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-002 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-003 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-004 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-005 | AB2 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205105-006 | AB2 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-001 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-002 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-003 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-004 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-005 | AB2 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205105-006 | AB2 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-001 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-002 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-003 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-004 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-005 | AB2 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205105-006 | AB2 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-001 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-002 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-003 | AB2 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205105-004 | AB2 | 1 | 2680178bc6a6… |
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 | METHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 10aa0dc0-bd0e-4927-a19a-8722d78ad67d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 205105 ANDA205105 0115-1739 0115-1740 0115-1738 0115-1736 0115-1737 0115-1741 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1736 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1737 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1738 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1739 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1740 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1741 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Impax Generics | ANDA | Current |
| 64720-401 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-402 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-403 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-404 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-405 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |
| 64720-406 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | CorePharma, LLC | ANDA | Current |