Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SUSPENSION;ORAL | 100,000 UNITS/ML | 0 | NYSTATIN | NYSTATIN |
002 | SUSPENSION;ORAL | 100,000 UNITS/ML | 0 | NYSTATIN | NYSTATIN |
FDA Submissions
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
VISTAPHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 64142
[companyName] => VISTAPHARM
[docInserts] => ["",""]
[products] => [{"drugName":"NYSTATIN","activeIngredients":"NYSTATIN","strength":"100,000 UNITS\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/25\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/64142ap_appltr_prntlbl_chemr.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NYSTATIN","submission":"NYSTATIN","actionType":"100,000 UNITS\/ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1998-06-25
)
)