NDA 210906

HQ SPCLT PHARMA

FDA Drug Application

Application #210906

Documents

• Label: 2018-10-31
• Letter: 2018-10-31
• Review: 2018-12-17
• Label: 2020-10-29
• Letter: 2020-11-02

Application Sponsors

NDA 210906

HQ SPCLT PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INTRAVENOUS	1GM/50ML (20MG/ML)	1	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE
002	SOLUTION;INTRAVENOUS	2GM/100ML (20MG/ML)	1	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE
003	SOLUTION;INTRAVENOUS	1GM/100ML (10MG/ML)	1	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-10-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15

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
        )

)