Application 204115
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 2.5MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | ||
| A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | ||
| A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 |
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 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204115-002 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204115-003 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204115-001 | METHYLPHENIDATE HYDROCHLORIDE | 2.5MG | TABLET, CHEWABLE / ORAL | 2015-02-25 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A204115-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204115-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A204115-003 | AB | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | A204115-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204115-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A204115-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204115-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204115-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204115-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204115-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A204115-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A204115-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204115-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A204115-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A204115-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204115-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A204115-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A204115-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204115-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A204115-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A204115-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204115-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A204115-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A204115-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204115-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A204115-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A204115-003 | AB | 1 | ea99ee380514… |
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 | Lupin Pharmaceuticals,Inc. | 5bfe50ed-171f-4c40-bc0b-20c68e8e2025 | 2023-12-11 | Boxed warning, Warnings, Adverse reactions | 204115 ANDA204115 43386-571 43386-572 43386-570 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 40032-570 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-570 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-571 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-571 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-572 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 40032-572 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Novel Laboratories, Inc. | ANDA | Current |
| 43386-570 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-570 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-570 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-571 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-571 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-571 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-572 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-572 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
| 43386-572 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Lupin Pharmaceuticals,Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10297 | ORIG | 2015-03-03 |