Documents
Application Sponsors
| NDA 021416 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | 1 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE |
| 002 | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | 1 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE |
| 003 | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | 1 | RYTHMOL SR | PROPAFENONE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2003-09-04 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2011-04-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 11 | AP | 2013-02-14 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2013-09-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2018-11-02 | STANDARD |
Submissions Property Types
| SUPPL | 7 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 21416
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"RYTHMOL SR","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RYTHMOL SR","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"325MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"RYTHMOL SR","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"425MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021416s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2013","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021416s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021416s010lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021416s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/04\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21416_rythmol_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RYTHMOL SR","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"225MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RYTHMOL SR","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"325MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"RYTHMOL SR","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"425MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-11-02
)
)