NDA 021019

GLAXOSMITHKLINE

FDA Drug Application

Application #021019

Documents

• Letter: 2001-04-03
• Review: 1999-10-06
• Letter: 1999-10-06
• Label: 1999-10-06

Application Sponsors

NDA 021019

GLAXOSMITHKLINE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE	0	COMPAZINE	PROCHLORPERAZINE MALEATE
002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE	0	COMPAZINE	PROCHLORPERAZINE MALEATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

1999-10-06

STANDARD

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21019
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMPAZINE","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"COMPAZINE","activeIngredients":"PROCHLORPERAZINE MALEATE","strength":"EQ 15MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/06\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/21019A_Compazine_appltrs_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMPAZINE","submission":"PROCHLORPERAZINE MALEATE","actionType":"EQ 10MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"COMPAZINE","submission":"PROCHLORPERAZINE MALEATE","actionType":"EQ 15MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-10-06
        )

)