Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018869
Company: BAYER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NIMOTOP NIMODIPINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/20/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf
08/22/2000 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf

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