HQ SPCLT PHARMA FDA Approval NDA 210906

NDA 210906

HQ SPCLT PHARMA

FDA Drug Application

Application #210906

Documents

Label2018-10-31
Letter2018-10-31
Review2018-12-17
Label2020-10-29
Letter2020-11-02

Application Sponsors

NDA 210906HQ SPCLT PHARMA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001SOLUTION;INTRAVENOUS1GM/50ML (20MG/ML)1CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE
002SOLUTION;INTRAVENOUS2GM/100ML (20MG/ML)1CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE
003SOLUTION;INTRAVENOUS1GM/100ML (10MG/ML)1CALCIUM GLUCONATE IN SODIUM CHLORIDECALCIUM GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2018-10-29STANDARD
LABELING; LabelingSUPPL4AP2020-10-28STANDARD

Submissions Property Types

ORIG1Null15
SUPPL4Null15

CDER Filings

HQ SPCLT PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210906
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM GLUCONATE IN SODIUM CHLORIDE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/50ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE IN SODIUM CHLORIDE","activeIngredients":"CALCIUM GLUCONATE","strength":"2GM\/100ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE IN SODIUM CHLORIDE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/28\/2020","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210906s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210906s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210906s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210906Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210906Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/28\/2020","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/210906s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210906Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-28
        )

)

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