Home Applications 202827 Application 202827
Type ANDA
Sponsor ROXANE Application Products# Product, Drug, Ingredient table 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 007 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202827-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 A202827-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 A202827-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 A202827-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 A202827-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 A202827-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 A202827-007 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
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.
Product history page 1 of 4 · 151 observed states.
Captured, Edition, Application-product table 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 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202827-007 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202827-007 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202827-007 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202827-007 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-006 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202827-007 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2024-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202827-001 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202827-002 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202827-003 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202827-004 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202827-005 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 151 observed states.
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 81542 ORIG 2025-03-24