Documents
Application Sponsors
NDA 213464 | BAYER HEALTHCARE PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 30MG | 0 | LAMPIT | NIFURTIMOX |
002 | TABLET;ORAL | 120MG | 0 | LAMPIT | NIFURTIMOX |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-08-06 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 2022-01-27 | STANDARD |
Submissions Property Types
CDER Filings
BAYER HEALTHCARE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 213464
[companyName] => BAYER HEALTHCARE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"LAMPIT","activeIngredients":"NIFURTIMOX","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LAMPIT","activeIngredients":"NIFURTIMOX","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213464s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213464s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213464Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-08-06
)
)