Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075725
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 80MG TABLET;ORAL Discontinued None No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 120MG TABLET;ORAL Discontinued None No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 160MG TABLET;ORAL Discontinued None No No
SOTALOL HYDROCHLORIDE SOTALOL HYDROCHLORIDE 240MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/19/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75725ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-725_Sotalol%20Hydrochloride.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/2021 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

05/22/2007 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

06/04/2003 SUPPL-1 Labeling

Label is not available on this site.

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