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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208003
Company: PRINSTON INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG 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
09/07/2022 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208003Orig1s000TAltr.pdf

FINGOLIMOD HYDROCHLORIDE

CAPSULE;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207991 ACCORD HLTHCARE
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 208004 ALKEM LABS LTD
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207993 APOTEX
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 208000 DR REDDYS
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207985 GLENMARK PHARMS LTD
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207939 HEC PHARM CO LTD
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207933 HETERO LABS LTD V
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 208005 MYLAN
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 208003 PRINSTON INC
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 208014 SUN PHARM
FINGOLIMOD HYDROCHLORIDE FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription No AB 207994 ZYDUS PHARMS
GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription Yes AB 022527 NOVARTIS
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