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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216256
Company: AMNEAL PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIMODIPINE NIMODIPINE 30MG/5ML(6MG/ML) SOLUTION;ORAL None (Tentative Approval) None No No
NIMODIPINE NIMODIPINE 60MG/10ML(6MG/ML) SOLUTION;ORAL 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
05/14/2024 ORIG-1 Tentative Approval STANDARD

Label is not available on this site.

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