ANDA 208269

ALVOGEN PINE BROOK

FDA Drug Application

Application #208269

Documents

• Letter: 2021-04-13

Application Sponsors

ANDA 208269

ALVOGEN PINE BROOK

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	20MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
002	TABLET, EXTENDED RELEASE;ORAL	30MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
003	TABLET, EXTENDED RELEASE;ORAL	40MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
004	TABLET, EXTENDED RELEASE;ORAL	60MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
005	TABLET, EXTENDED RELEASE;ORAL	80MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
006	TABLET, EXTENDED RELEASE;ORAL	100MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
007	TABLET, EXTENDED RELEASE;ORAL	120MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-03-01

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB
006	Prescription	AB
007	Prescription	AB

CDER Filings

ALVOGEN PINE BROOK

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208269
            [companyName] => ALVOGEN PINE BROOK
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"40MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"80MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-01
        )

)