Application 210924
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 8.6MG | No | No |
| 002 | METHYLPHENIDATE | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 17.3MG | No | No |
| 003 | METHYLPHENIDATE | METHYLPHENIDATE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | 25.9MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210924-001 | METHYLPHENIDATE | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | |
| A210924-002 | METHYLPHENIDATE | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | |
| A210924-003 | METHYLPHENIDATE | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210924-001 | AB |
| A210924-002 | AB |
| A210924-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | 2020-06-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210924-002 | METHYLPHENIDATE | 17.3MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A210924-003 | METHYLPHENIDATE | 25.9MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A210924-001 | METHYLPHENIDATE | 8.6MG | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | 2020-06-19 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210924-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210924-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210924-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210924-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210924-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210924-003 | AB | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210924-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210924-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210924-003 | AB | 1 | a50c72e98297… |
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 | METHYLPHENIDATE HYDROCHLORIDE | KVK-Tech, Inc. | 2cf1b26b-199d-4c7f-ab64-4805a9def2cc | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | Methylphenidate |
| Methylphenidate | METHYLPHENIDATE | Mylan Pharmaceuticals Inc. | 1643b6a5-80da-4d4f-8c5f-feb907875702 | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | Methylphenidate METHYLPHENIDATE |
| Methylphenidate Transdermal System | METHYLPHENIDATE | PADAGIS US LLC | 7bcff873-1fc2-45bc-a8e4-5db4edeb9bfb | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE |
| Cotempla XR-ODT | METHYLPHENIDATE | Neos Therapeutics Brands, LLC | 33f70f58-c871-42c8-8adb-345caeafefcd | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE |
| Methylphenidate | METHYLPHENIDATE | Sandoz Inc | 1f8983ce-71b8-4c62-830d-e4692ddededa | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | Methylphenidate METHYLPHENIDATE |
| Methylphenidate | METHYLPHENIDATE | Sandoz Inc | 44386394-d2a3-4483-abe1-6c5c634cc501 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | Methylphenidate METHYLPHENIDATE |
| Daytrana | METHYLPHENIDATE | Noven Therapeutics, LLC | 2c312c31-3198-4775-91ab-294e0b4b9e7f | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | METHYLPHENIDATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 57275 | ORIG | 2019-01-18 |