Application 202830
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 20MG | No | No |
| 002 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 30MG | No | No |
| 003 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 40MG | No | No |
| 004 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 50MG | No | No |
| 005 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | CAPSULE;ORAL | 60MG | No | No |
| 006 | 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 |
|---|---|---|---|---|---|---|---|
| A202830-001 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A202830-002 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A202830-003 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A202830-004 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A202830-005 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | |
| A202830-006 | LISDEXAMFETAMINE DIMESYLATE | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202830-001 | AB |
| A202830-002 | AB |
| A202830-003 | AB |
| A202830-004 | AB |
| A202830-005 | AB |
| A202830-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A202830-001 | LISDEXAMFETAMINE DIMESYLATE | 20MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202830-002 | LISDEXAMFETAMINE DIMESYLATE | 30MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202830-003 | LISDEXAMFETAMINE DIMESYLATE | 40MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202830-004 | LISDEXAMFETAMINE DIMESYLATE | 50MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202830-005 | LISDEXAMFETAMINE DIMESYLATE | 60MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A202830-006 | LISDEXAMFETAMINE DIMESYLATE | 70MG | CAPSULE / ORAL | AB | 2023-08-25 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A202830-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202830-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202830-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202830-004 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202830-005 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A202830-006 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | LISDEXAMFETAMINE | Amneal Pharmaceuticals LLC | c11cb3b6-3dff-477b-a249-b4c3118edc5f | 2026-05-01 | Boxed warning, Warnings, Adverse reactions | 202830 ANDA202830 |
| Lisdexamfetamine Dimesylate | LISDEXAMFETAMINE | AvKARE | 36c40404-fe94-6fb7-e063-6394a90a2657 | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | 202830 ANDA202830 |