Application 209753
- Type
- ANDA
- Sponsor
- BIONPHARMA INC
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 |
|---|---|---|---|---|---|---|---|
| A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | |
| A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | |
| A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209753-001 | AB |
| A209753-002 | AB |
| A209753-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-002 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2018-03-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-003 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2018-03-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209753-001 | METHYLPHENIDATE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2018-03-02 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209753-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209753-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209753-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209753-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209753-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209753-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209753-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209753-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209753-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209753-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209753-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209753-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209753-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209753-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209753-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209753-001 | AB | 1 | 8072bd15b7f6… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69452-165 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |
| 69452-165 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |
| 69452-166 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |
| 69452-166 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |
| 69452-167 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |
| 69452-167 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | Bionpharma Inc. | ANDA | Current |