Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022306
Company: ALTATHERA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 150MG/10ML (15MG/ML) SOLUTION;INTRAVENOUS 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
07/02/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022306s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306_sotalol_hydrochloride_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022306s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/06/2020 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022306s005lblrpl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022306Orig1s005_Replacement_ltr.pdf
09/25/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/06/2013 SUPPL-3 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
03/06/2020 SUPPL-5 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022306s005lblrpl.pdf
07/02/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022306s000lbl.pdf

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