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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205108
Company: AZURITY

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTYLIZE SOTALOL HYDROCHLORIDE 5MG/ML (5MG/ML) SOLUTION;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
10/22/2014 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205108s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205108Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205108Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2024 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205108s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205108Orig1s003ltr.pdf
06/16/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/12/2024 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205108s003lbl.pdf
10/22/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205108s000lbl.pdf
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