SANDOZ INC FDA Approval ANDA 091620

ANDA 091620

SANDOZ INC

FDA Drug Application

Application #091620

Application Sponsors

ANDA 091620SANDOZ INC

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUS50MG/VIAL0TIGECYCLINETIGECYCLINE

FDA Submissions

ORIG1AP2015-05-27
LABELING; LabelingSUPPL2AP2017-09-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2017-09-29
LABELING; LabelingSUPPL6AP2020-04-09STANDARD
LABELING; LabelingSUPPL7AP2020-04-09STANDARD
LABELING; LabelingSUPPL10AP2021-01-25STANDARD

Submissions Property Types

ORIG1Null19
SUPPL2Null7
SUPPL3Null7
SUPPL6Null15
SUPPL7Null15
SUPPL10Null15

TE Codes

001PrescriptionAP

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91620
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGECYCLINE","activeIngredients":"TIGECYCLINE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TIGECYCLINE","submission":"TIGECYCLINE","actionType":"50MG\/VIAL","submissionClassification":"POWDER;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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