Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210500
Company: HETERO LABS LTD III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIMETHYL FUMARATE DIMETHYL FUMARATE UNKNOWN UNKNOWN None (Tentative Approval) None 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
02/21/2019 ORIG-1 Tentative Approval STANDARD Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210500Orig1s000TAltr.pdf

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