Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206836
Company: ACTAVIS LABS FL INC
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.

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 206836 ACTAVIS LABS FL INC
DALFAMPRIDINE DALFAMPRIDINE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206811 AUROBINDO PHARMA LTD

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