Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022102
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALOMIST CYANOCOBALAMIN 25MCG/SPRAY SPRAY, METERED;NASAL 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
07/27/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102_calomist_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022102s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2009 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022102s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2009 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf
03/24/2009 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022102s003lbl.pdf
07/27/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022102s000lbl.pdf

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