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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216493
Company: HANGZHOU ZHONGMEI

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) SOLUTION;SUBCUTANEOUS Discontinued None No No
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) SOLUTION;SUBCUTANEOUS Discontinued None No No
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) SOLUTION;SUBCUTANEOUS Discontinued None No No
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) SOLUTION;SUBCUTANEOUS Discontinued 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
08/19/2024 ORIG-1 Approval STANDARD

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