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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208342
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIGLUSTAT MIGLUSTAT 100MG 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
04/17/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208342Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2021 SUPPL-3 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

11/14/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

MIGLUSTAT

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIGLUSTAT MIGLUSTAT 100MG CAPSULE;ORAL Prescription No AB 208342 ANI PHARMS
MIGLUSTAT MIGLUSTAT 100MG CAPSULE;ORAL Prescription No AB 209325 BRECKENRIDGE
MIGLUSTAT MIGLUSTAT 100MG CAPSULE;ORAL Prescription No AB 209821 EDENBRIDGE PHARMS
ZAVESCA MIGLUSTAT 100MG CAPSULE;ORAL Prescription Yes AB 021348 ACTELION
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