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NDA

LISDEXAMFETAMINE DIMESYLATE | N208510 | TAKEDA PHARMACEUTICALS USA INC

6 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

VERANOVA LPLISDEXAMFETAMINE DIMESYLATE

DMF 224422009

CHATTEM CHEMICALS INCLISDEXAMFETAMINE DIMESYLATE

DMF 322892018

SPECGX LLCLISDEXAMFETAMINE DIMESYLATE

DMF 348232020

NORAMCO LLCLISDEXAMFETAMINE DIMESYLATE DRUG SUBSTANCE

DMF 356452021

AUGUST PHARMACEUTICALS LLCLISDEXAMFETAMINE DIMESYLATE INT

DMF 357542021

ALKEM LABORATORIES LTDLISDEXAMFETAMINE DIMESYLATE

DMF 386672023

VERANOVA LPLISDEXAMFETAMINE DIMESYLATE B1625

DMF 388742023

GRANULES INDIA LTDLISDEXAMFETAMINE DIMESYLATE

DMF 417372025

COHANCE LIFESCIENCES LTDLISDEXAMFETAMINE

DMF 422822025

SPECGX LLCInactiveLISDEXAMFETAMINE DIMESYLATE

DMF 322102017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

9 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (6)

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#001 — 10MG

RLDAB

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