Application 040404
- Type
- ANDA
- Sponsor
- ABLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | ||
| A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | ||
| A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 |
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 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040404-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2001-03-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040404-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | 2001-03-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040404-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2001-03-29 | 1e350fbaab3a… |
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 CD | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, LLC | e45c75dc-d381-475b-b649-a871c8a36e60 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METADATE CD | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, LLC | 29f06562-6b6a-4ca6-b62e-d08a45fb3dd4 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Rhodes Pharmaceuticals LLC | f7a7ffd1-bc30-4db8-8391-dddf76acd639 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, Inc. | 44737c1d-fe75-409e-8a58-591696d3d7aa | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 10aa0dc0-bd0e-4927-a19a-8722d78ad67d | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate | METHYLPHENIDATE HYDROCHLORIDE | KVK-Tech, Inc. | 2cf1b26b-199d-4c7f-ab64-4805a9def2cc | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Lannett Company, Inc. | 3d1f5aff-5d39-496c-b5ed-7f3c70ec641c | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Actavis Pharma, Inc. | 85ef422d-af27-4126-9841-6892af1871d6 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Trigen Laboratories, LLC | c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 18024571-4505-6d51-e063-6294a90a1972 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 98be5c84-b348-6b8e-e053-2995a90ae4cc | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 22e5ddfa-7264-fbb1-e063-6394a90a6483 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | Janssen Pharmaceuticals, Inc. | 1a88218c-5b18-4220-8f56-526de1a276cd | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| QuilliChew ER | METHYLPHENIDATE HYDROCHLORIDE | NextWave Pharmaceuticals, Inc | defc1205-8e90-4b1e-b862-05e4c35c7364 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Northstar Rx LLC | 768bf181-d0d8-49e5-9c87-cacbb069e0b2 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Quillivant XR | METHYLPHENIDATE HYDROCHLORIDE | NextWave Pharmaceuticals, Inc | c2dc2109-44a6-4797-b04e-18761dd9d45a | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | cd2c1226-fa19-4734-b62d-89fea73dcb0d | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | Bryant Ranch Prepack | 5a29687b-5294-4b27-a556-514b092a877d | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride | METHYLPHENIDATE HYDROCHLORIDE | KVK-TECH, INC. | 1bf37f9f-29cf-4b09-9c81-eb369e35a042 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | Methylphenidate Hydrochloride METHYLPHENIDATE HYDROCHLORIDE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 29949 | ORIG | 2001-03-29 |