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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215430
Company: AXSOME

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AUVELITY BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE 105MG;45MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/18/2022 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215430Orig1s000Correctedltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/07/2024 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215430s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215430Orig1s008ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/07/2024 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215430s008lbl.pdf
08/18/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215430Orig1s000Correctedlbl.pdf
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