BAXTER HLTHCARE CORP FDA Approval ANDA 208084

ANDA 208084

BAXTER HLTHCARE CORP

FDA Drug Application

Application #208084

Application Sponsors

ANDA 208084BAXTER HLTHCARE CORP

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 6MG BASE/ML0CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATE
002INJECTABLE;INJECTIONEQ 12MG BASE/ML0CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATE
003INJECTABLE;INJECTIONEQ 18MG BASE/ML0CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINERCLINDAMYCIN PHOSPHATE

FDA Submissions

UNKNOWN; ORIG1AP2017-06-28STANDARD
LABELING; LabelingSUPPL2AP2020-05-14STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208084
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 6MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 12MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER","activeIngredients":"CLINDAMYCIN PHOSPHATE","strength":"EQ 18MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/14\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-14
        )

)

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