Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208411
Company: ADAPT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NARCAN NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED;NASAL Prescription None Yes Yes
NARCAN NALOXONE HYDROCHLORIDE 2MG/SPRAY SPRAY, METERED;NASAL Discontinued None Yes 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
11/18/2015 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/208411Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208411Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2017 SUPPL-1 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208411s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208411Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2017/208411s001SumR.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/24/2017 SUPPL-1 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208411s001lbl.pdf
11/18/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf

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