ANDA 090132

SUN PHARM INDUSTRIES

FDA Drug Application

Application #090132

Documents

• Letter: 2017-11-08

Application Sponsors

ANDA 090132

SUN PHARM INDUSTRIES

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG	0	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE
002	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE
003	CAPSULE, EXTENDED RELEASE;ORAL	40MG	0	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE
004	CAPSULE, EXTENDED RELEASE;ORAL	80MG	0	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE

FDA Submissions

ORIG

1

AP

2017-10-25

Submissions Property Types

ORIG

1

Null

29

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90132
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARVEDILOL PHOSPHATE","activeIngredients":"CARVEDILOL PHOSPHATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL PHOSPHATE","activeIngredients":"CARVEDILOL PHOSPHATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL PHOSPHATE","activeIngredients":"CARVEDILOL PHOSPHATE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARVEDILOL PHOSPHATE","activeIngredients":"CARVEDILOL PHOSPHATE","strength":"80MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARVEDILOL PHOSPHATE","submission":"CARVEDILOL PHOSPHATE","actionType":"10MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL PHOSPHATE","submission":"CARVEDILOL PHOSPHATE","actionType":"20MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL PHOSPHATE","submission":"CARVEDILOL PHOSPHATE","actionType":"40MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CARVEDILOL PHOSPHATE","submission":"CARVEDILOL PHOSPHATE","actionType":"80MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)