Application Sponsors
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 0 | DALFAMPRIDINE | DALFAMPRIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-05-21 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2020-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2021-09-08 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2022-07-28 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 15 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 7 |
TE Codes
CDER Filings
SUN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 208292
[companyName] => SUN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/21\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/14\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-14
)
)