Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 225MG | 0 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE |
002 | CAPSULE, EXTENDED RELEASE;ORAL | 325MG | 0 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE |
003 | CAPSULE, EXTENDED RELEASE;ORAL | 425MG | 0 | PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-06-18 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
TWI PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 212928
[companyName] => TWI PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"225MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"325MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROPAFENONE HYDROCHLORIDE","activeIngredients":"PROPAFENONE HYDROCHLORIDE","strength":"425MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-06-18
)
)