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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022306
Company: ALTATHERA PHARMS LLC

Summary Review

Products on NDA 022306

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022306

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
09/21/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022306s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022306Orig1s006ltr.pdf
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.

Labels for NDA 022306

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/21/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022306s006lbl.pdf
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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