Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 211243
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPRAVATO ESKETAMINE HYDROCHLORIDE EQ 28MG BASE SPRAY;NASAL 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
03/05/2019 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211243Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2019 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211243Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2019 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243s001lbl.pdf
03/05/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211243lbl.pdf

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