Documents
Application Sponsors
| NDA 019151 | GLAXOSMITHKLINE LLC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | TABLET;ORAL | 150MG | 1 | RYTHMOL | PROPAFENONE HYDROCHLORIDE |
| 002 | TABLET;ORAL | 300MG | 1 | RYTHMOL | PROPAFENONE HYDROCHLORIDE |
| 003 | TABLET;ORAL | 225MG | 1 | RYTHMOL | PROPAFENONE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1989-11-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 1997-12-23 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1993-11-23 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1997-03-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1999-09-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-07-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2002-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-01-11 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2013-03-20 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-07-11 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2018-11-02 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 7 |
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 19151
[companyName] => GLAXOSMITHKLINE LLC
[docInserts] => ["",""]
[products] => [{"drugName":"RYTHMOL","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RYTHMOL","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"RYTHMOL","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[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\\\/019151s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/20\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019151s012lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"RYTHMOL","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RYTHMOL","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"RYTHMOL","submission":"PROPAFENONE HYDROCHLORIDE","actionType":"225MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-11-02
)
)