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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206811
Company: AUROBINDO PHARMA
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
01/23/2017 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
05/01/2023 SUPPL-9 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/29/2021 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

08/13/2020 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/27/2019 SUPPL-2 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 MERZ PHARMS
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
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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