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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208969
Company: AMPHASTAR PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REXTOVY NALOXONE HYDROCHLORIDE 4MG/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
03/07/2023 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208969Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/208969Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2023 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208969Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2023 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf
06/29/2023 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s001lbl.pdf
03/07/2023 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208969s000lbl.pdf
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