NDA 209478

CMP DEV LLC

FDA Drug Application

Application #209478

Documents

• Label: 2017-08-08
• Letter: 2017-08-15
• Review: 2018-04-10
• Label: 2021-06-28
• Letter: 2021-06-29
• Letter: 2021-09-08
• Label: 2021-09-08

Application Sponsors

NDA 209478

CMP DEV LLC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

25MG/5ML

1

CAROSPIR

SPIRONOLACTONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-08-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2021-07-15	N/A
LABELING; Labeling	SUPPL	3	AP	2021-06-25	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7

CDER Filings

CMP DEV LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209478
            [companyName] => CMP DEV LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CAROSPIR","activeIngredients":"SPIRONOLACTONE","strength":"25MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/15\/2021","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209478Orig1s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209478s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209478s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/04\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209478s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209478Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209478Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/25\/2021","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209478s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209478Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"07\/15\/2021","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209478Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209478Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-07-15
        )

)