U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 212463
Company: AIZANT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELIGLUSTAT TARTRATE ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/08/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212463Orig1s000ltr.pdf

ELIGLUSTAT TARTRATE

CAPSULE;ORAL; EQ 84MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CERDELGA ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE;ORAL Prescription Yes AB 205494 GENZYME CORP
ELIGLUSTAT TARTRATE ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE;ORAL Prescription No AB 212463 AIZANT
ELIGLUSTAT TARTRATE ELIGLUSTAT TARTRATE EQ 84MG BASE CAPSULE;ORAL Prescription No AB 212449 DR REDDYS
Back to Top