Application 089601
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METADATE ER | METHYLPHENIDATE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A089601-001 | METADATE ER | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 |
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 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A089601-001 | METADATE ER | 20MG | TABLET, EXTENDED RELEASE / ORAL | 1988-06-01 | cb3db0bc1861… |
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 | Granules Pharmaceuticals Inc. | 45d33807-88b2-4b42-9c86-e5b05d7adec1 | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | 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 | Lannett Company, Inc. | 44737c1d-fe75-409e-8a58-591696d3d7aa | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 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 | 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 | Actavis Pharma, Inc. | 85ef422d-af27-4126-9841-6892af1871d6 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 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 | Sun Pharmaceutical Industries, Inc. | 18024571-4505-6d51-e063-6294a90a1972 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 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 | Golden State Medical Supply, Inc. | 22e5ddfa-7264-fbb1-e063-6394a90a6483 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | 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 |
| 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 | Bryant Ranch Prepack | 5a29687b-5294-4b27-a556-514b092a877d | 2026-03-17 | Boxed warning, Warnings, Adverse reactions | 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 | METHYLPHENIDATE HYDROCHLORIDE | American Health Packaging | f6581305-cd1e-4171-8c1b-e184c7bde033 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
| Methylphenidate Hydrochloride Extended-Release | METHYLPHENIDATE HYDROCHLORIDE | SpecGx LLC | 9e11e093-4ff3-4bed-8fe9-3ee460b47303 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-2562 | Metadate ER | methylphenidate hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-2562 | Metadate ER | methylphenidate hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 53014-594 | Metadate ER | methylphenidate hydrochloride | Unither Manufacturing, LLC | ANDA | Current |
| 65580-594 | Metadate ER | methylphenidate hydrochloride | Upstate Pharma, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44412 | ORIG | 2007-05-18 |