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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206765
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;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
07/30/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2021 SUPPL-7 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/15/2021 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

DALFAMPRIDINE

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPYRA DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022250 ACORDA
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206863 ACCORD HLTHCARE
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206836 ACTAVIS LABS FL INC
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206765 ALKEM LABS LTD
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206811 AUROBINDO PHARMA LTD
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210158 MICRO LABS
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208292 SUN PHARM
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