ANDA 206986

ALVOGEN

FDA Drug Application

Application #206986

Documents

• Letter: 2020-03-18

Application Sponsors

ANDA 206986

ALVOGEN

Marketing Status

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

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	10MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
002	CAPSULE, EXTENDED RELEASE;ORAL	15MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
003	CAPSULE, EXTENDED RELEASE;ORAL	20MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
004	CAPSULE, EXTENDED RELEASE;ORAL	30MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
005	CAPSULE, EXTENDED RELEASE;ORAL	40MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE
006	CAPSULE, EXTENDED RELEASE;ORAL	50MG	0	HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-01-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

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

CDER Filings

ALVOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206986
            [companyName] => ALVOGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"10MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"15MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"20MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"30MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"40MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE","activeIngredients":"HYDROCODONE BITARTRATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206986Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-01-21
        )

)