ANDA 064142

VISTAPHARM

FDA Drug Application

Application #064142

Documents

• Letter: 1998-06-25
• Label: 1998-06-25
• Review: 1998-06-25

Application Sponsors

ANDA 064142

VISTAPHARM

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

ORIG

1

AP

1998-06-25

Submissions Property Types

SUPPL

1

Null

0

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
        )

)