NDA 210428

SPIL

FDA Drug Application

Application #210428

Documents

• Label: 2018-01-30
• Letter: 2018-01-30
• Label: 2018-05-17
• Review: 2018-10-11
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 210428

SPIL

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 25MG TARTRATE	1	KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 50MG TARTRATE	1	KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE
003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 100MG TARTRATE	1	KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE
004	CAPSULE, EXTENDED RELEASE;ORAL	EQ 200MG TARTRATE	1	KAPSPARGO SPRINKLE	METOPROLOL SUCCINATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2018-01-26

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

SPIL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210428
            [companyName] => SPIL
            [docInserts] => ["",""]
            [products] => [{"drugName":"KAPSPARGO SPRINKLE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 25MG TARTRATE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KAPSPARGO SPRINKLE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KAPSPARGO SPRINKLE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KAPSPARGO SPRINKLE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210428s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210428s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210428s000lblReplacement.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/26\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210428s000lblReplacement.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210428Orig1s000Replacementltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210428Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210428s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2018-05-14
        )

)