Application 215330
- Type
- ANDA
- Sponsor
- RHODES PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 10MG | No | No |
| 002 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 20MG | No | No |
| 003 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 30MG | No | No |
| 004 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 40MG | No | No |
| 005 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 50MG | No | No |
| 006 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 60MG | No | No |
| 007 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 70MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215330-001 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-002 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-003 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-004 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-005 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-006 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A215330-007 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A215330-001 | AB |
| A215330-002 | AB |
| A215330-003 | AB |
| A215330-004 | AB |
| A215330-005 | AB |
| A215330-006 | AB |
| A215330-007 | 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 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-006 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-007 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-006 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-007 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-006 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-007 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-006 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-007 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-006 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-007 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-001 | LISDEXAMFETAMINE DIMESYLATE | 10MG | CAPSULE / ORAL | AB | 2023-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-002 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-003 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-004 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-005 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A215330-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A215330-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215330-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A215330-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215330-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215330-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215330-005 | AB | 1 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 281842ea-d165-4b6d-a366-791239be8c2e | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Rhodes Pharmaceuticals LLC | d918b40d-a461-41bc-b6c0-83dc76c28e32 | 2026-05-08 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 483cc379-fd34-45aa-a5c0-09c4d0c167d9 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 768d3b93-c1c6-4bf2-a4d8-cee017ab4a16 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | b548020c-dd53-4929-96d6-175a78eba5bb | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 3b69003f-f7b4-4e52-acde-4b229d6c51fe | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 5eab8a4f-0438-4f5c-8f32-53cc98ea134b | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |
| LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | Bryant Ranch Prepack | 18a97c88-0f72-4b02-be0d-4d093886cca5 | 2026-03-16 | Boxed warning, Warnings, Adverse reactions | 215330 ANDA215330 |