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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208262
Company: WOCKHARDT BIO AG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PEMETREXED SODIUM PEMETREXED SODIUM 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
05/23/2019 ORIG-1 Tentative Approval STANDARD

Label is not available on this site.

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