ANDA 206948

PURACAP PHARM LLC

FDA Drug Application

Application #206948

Application Sponsors

ANDA 206948

PURACAP PHARM LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	100MG	0	BENZONATATE	BENZONATATE
002	CAPSULE;ORAL	200MG	0	BENZONATATE	BENZONATATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-12-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

PURACAP PHARM LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206948
            [companyName] => PURACAP PHARM LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-19
        )

)