ANDA 203412

HAINAN POLY PHARM

FDA Drug Application

Application #203412

Documents

• Letter: 2015-10-21

Application Sponsors

ANDA 203412

HAINAN POLY PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 500MG BASE/VIAL

0

AZITHROMYCIN

AZITHROMYCIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-10-09
LABELING; Labeling	SUPPL	2	AP	2020-04-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HAINAN POLY PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203412
            [companyName] => HAINAN POLY PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/09\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203412Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/19\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-19
        )

)