Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021279
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FORADIL FORMOTEROL FUMARATE 0.012MG/INH POWDER; INHALATION Prescription 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
09/25/2001 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21279ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021279s000_ForadilTOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20831s2lbl.pdf

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