ANDA 208593

ABHAI LLC

FDA Drug Application

Application #208593

Documents

• Letter: 2017-07-25

Application Sponsors

ANDA 208593

ABHAI LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	5MG/5ML	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	SOLUTION;ORAL	100MG/5ML	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-21

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

ABHAI LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208593
            [companyName] => ABHAI LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"100MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208593Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-1","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)