NDA 209463

HIKMA

FDA Drug Application

Application #209463

Documents

• Label: 2017-07-03
• Letter: 2017-07-05
• Review: 2018-02-21
• Label: 2018-10-11
• Letter: 2018-10-15
• Letter: 2018-10-15
• Label: 2020-06-24
• Letter: 2020-06-24
• Label: 2020-11-30
• Letter: 2020-12-01
• Letter: 2022-01-05
• Letter: 2022-03-07
• Label: 2022-03-10

Application Sponsors

NDA 209463

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;IV (INFUSION)

EQ 40MG BASE/VIAL

1

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-06-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-10-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-06-23	STANDARD
LABELING; Labeling	SUPPL	11	AP	2020-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	TA	2021-07-26	N/A
LABELING; Labeling	SUPPL	15	AP	2022-03-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	6
SUPPL	11	Null	15
SUPPL	15	Null	6

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209463
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"PANTOPRAZOLE SODIUM","activeIngredients":"PANTOPRAZOLE SODIUM","strength":"EQ 40MG BASE\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209463s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209463s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209463s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/30\/2017","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\\\/2017\\\/209463s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209463Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209463Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209463s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209463Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/10\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209463s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209463Orig1s005Ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209463Orig1s005Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-23
        )

)