NDA 208418

FRESENIUS KABI USA

FDA Drug Application

Application #208418

Documents

• Label: 2017-06-16
• Letter: 2017-06-16
• Pediatric Medical Review: 1900-01-01
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Review: 2018-05-17
• Review: 2018-06-05
• Letter: 2021-06-22
• Label: 2021-06-23
• Letter: 2021-12-30
• Label: 2022-01-04
• Letter: 2022-10-18
• Label: 2022-10-19

Application Sponsors

NDA 208418

FRESENIUS KABI USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	SOLUTION;INTRAVENOUS	1GM/10ML (100MG/ML)	1	CALCIUM GLUCONATE	CALCIUM GLUCONATE
002	SOLUTION;INTRAVENOUS	5GM/50ML (100MG/ML)	1	CALCIUM GLUCONATE	CALCIUM GLUCONATE
003	SOLUTION;INTRAVENOUS	10GM/100ML (100MG/ML)	1	CALCIUM GLUCONATE	CALCIUM GLUCONATE
004	SOLUTION;INTRAVENOUS	1GM/50ML (20MG/ML)	1	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE
005	SOLUTION;INTRAVENOUS	2GM/100ML (20MG/ML)	1	CALCIUM GLUCONATE IN SODIUM CHLORIDE	CALCIUM GLUCONATE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA	ORIG	1	AP	2017-06-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	2021-06-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-12-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-10-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	7	Null	15
SUPPL	11	Null	6
SUPPL	13	Null	15

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

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(
    [0] => Array
        (
            [ApplNo] => 208418
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"1GM\/10ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"5GM\/50ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CALCIUM GLUCONATE","activeIngredients":"CALCIUM GLUCONATE","strength":"10GM\/100ML (100MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208418s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208418s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208418Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208418Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/22\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/review\\\/2018\\\/208418Orig1s001.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-12-22
        )

)