Application 079031
- Type
- ANDA
- Sponsor
- BARR LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 20MG | No | No |
| 002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 40MG | No | No |
| 004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | ||
| A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 |
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 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079031-001 | METHYLPHENIDATE HYDROCHLORIDE | 20MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079031-002 | METHYLPHENIDATE HYDROCHLORIDE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079031-003 | METHYLPHENIDATE HYDROCHLORIDE | 40MG | CAPSULE, EXTENDED RELEASE / ORAL | 2012-07-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A079031-004 | METHYLPHENIDATE HYDROCHLORIDE | 10MG | CAPSULE, EXTENDED RELEASE / ORAL | 2014-10-15 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A079031-001 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-002 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-003 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A079031-004 | AB1 | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-001 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-002 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-003 | AB1 | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A079031-004 | AB1 | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-001 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-002 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-003 | AB1 | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A079031-004 | AB1 | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-001 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-002 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-003 | AB1 | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A079031-004 | AB1 | 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 (LA) | METHYLPHENIDATE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 034fb7cd-e183-475e-8beb-64fd88facc8f | 2019-12-31 | Boxed warning, Warnings, Adverse reactions | 079031 ANDA079031 0093-5348 0093-5346 0093-5347 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-5346 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5346 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5346 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5346 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5347 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5347 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5347 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5347 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5348 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5348 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5348 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5348 | Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |