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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019151
Company: GLAXOSMITHKLINE LLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYTHMOL PROPAFENONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
RYTHMOL PROPAFENONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
RYTHMOL PROPAFENONE HYDROCHLORIDE 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/02/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019151s015lbl.pdf
03/20/2013 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019151s012lbl.pdf
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