SUN PHARM INDS INC FDA Approval ANDA 064171

ANDA 064171

SUN PHARM INDS INC

FDA Drug Application

Application #064171

Application Sponsors

ANDA 064171SUN PHARM INDS INC

Marketing Status

Prescription001

Application Products

001CAPSULE;ORALEQ 250MG BASE0PAROMOMYCIN SULFATEPAROMOMYCIN SULFATE

FDA Submissions

ORIG1AP1997-06-30

Submissions Property Types

SUPPL1Null0

TE Codes

001PrescriptionAA

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64171
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PAROMOMYCIN SULFATE","activeIngredients":"PAROMOMYCIN SULFATE","strength":"EQ 250MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PAROMOMYCIN SULFATE","submission":"PAROMOMYCIN SULFATE","actionType":"EQ 250MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.