ANDA 205177

ANI PHARMS INC

FDA Drug Application

Application #205177

Documents

• Letter: 2016-04-04

Application Sponsors

ANDA 205177

ANI PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

5MG

0

OXYCODONE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-31	STANDARD
REMS; REMS	SUPPL	4	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

ANI PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205177
            [companyName] => ANI PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205177Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)