ANDA 206586

PAR STERILE PRODUCTS

FDA Drug Application

Application #206586

Documents

• Letter: 2015-07-30

Application Sponsors

ANDA 206586

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 0.3MG BASE/ML

0

BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-07-28	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-06-23	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	5	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206586
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPRENORPHINE HYDROCHLORIDE","activeIngredients":"BUPRENORPHINE HYDROCHLORIDE","strength":"EQ 0.3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206586Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-23
        )

)