Application 079108
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
| 003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | |
| A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | |
| A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | |
| A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | |
| A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079108-001 | AB |
| A079108-002 | AB |
| A079108-003 | AB |
| A079108-004 | AB |
| A079108-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-001 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-002 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-08-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-003 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2014-05-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-004 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2015-12-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-005 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2013-11-21 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A079108-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079108-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079108-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079108-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079108-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079108-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079108-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079108-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079108-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079108-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079108-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079108-005 | AB | 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 |
|---|---|---|---|---|---|---|
| Dexmethylphenidate hydrochloride | DEXMETHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 93e56455-0f15-4ed9-a63a-7fbd0697d520 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 079108 ANDA079108 0115-9921 0115-9922 0115-9920 0115-9919 0115-9918 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0115-1682 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1682 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1682 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-1682 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1683 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1683 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1683 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-1683 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1684 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1684 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1684 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-1684 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1685 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1685 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1685 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-1685 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1686 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1686 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1686 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-1686 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9918 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9919 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9920 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9921 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Impax Generics | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-9922 | Dexmethylphenidate hydrochloride | Dexmethylphenidate hydrochloride | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31411 | ORIG | 2013-12-05 |