Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021416
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB 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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

RYTHMOL SR

CAPSULE, EXTENDED RELEASE;ORAL; 225MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN PHARMS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 225MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

CAPSULE, EXTENDED RELEASE;ORAL; 325MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN PHARMS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 325MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

CAPSULE, EXTENDED RELEASE;ORAL; 425MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205268 GLENMARK PHARMS LTD
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203803 MYLAN PHARMS INC
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 078540 PAR PHARM
PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202688 WATSON LABS INC
RYTHMOL SR PROPAFENONE HYDROCHLORIDE 425MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 021416 GLAXOSMITHKLINE LLC

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