SANDOZ INC FDA Approval ANDA 090296

ANDA 090296

SANDOZ INC

FDA Drug Application

Application #090296

Application Sponsors

ANDA 090296SANDOZ INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;IV (INFUSION)EQ 40MG BASE/VIAL0PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUM

FDA Submissions

ORIG1AP2015-07-14
LABELING; LabelingSUPPL2AP2019-09-16STANDARD
LABELING; LabelingSUPPL3AP2019-09-16STANDARD
LABELING; LabelingSUPPL5AP2019-09-16STANDARD
LABELING; LabelingSUPPL6AP2019-09-16STANDARD
LABELING; LabelingSUPPL7AP2021-03-05STANDARD
LABELING; LabelingSUPPL8AP2022-07-28STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null7
SUPPL3Null15
SUPPL5Null7
SUPPL6Null15
SUPPL7Null15
SUPPL8Null15

TE Codes

001PrescriptionAP

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90296
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PANTOPRAZOLE SODIUM","submission":"PANTOPRAZOLE SODIUM","actionType":"EQ 40MG BASE\/VIAL","submissionClassification":"INJECTABLE;IV (INFUSION)","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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