Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207979
Company: BIOCON LTD
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
12/04/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

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 207979 BIOCON 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 208014 SUN PHARM
GILENYA FINGOLIMOD HYDROCHLORIDE EQ 0.5MG BASE CAPSULE;ORAL Prescription Yes AB 022527 NOVARTIS

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