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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021416
Company: GLAXOSMITHKLINE LLC

Products on NDA 021416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	225MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	325MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
RYTHMOL SR	PROPAFENONE HYDROCHLORIDE	425MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/04/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21416ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-416_Rythmol.html

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021416s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021416Orig1s015Ltr.pdf
07/11/2014	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/09/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/14/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf
04/13/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021416s010ltr.pdf
10/29/2010	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021416s007ltr.pdf
09/13/2004	SUPPL-1	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21416s001ltr.pdf

Labels for NDA 021416

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/2018/021416s015lbl.pdf
02/14/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf
04/13/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf
10/29/2010	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf
09/04/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf

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