ANDA 212332

HAINAN POLY PHARM

FDA Drug Application

Application #212332

Application Sponsors

ANDA 212332

HAINAN POLY PHARM

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-06-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-04-07	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HAINAN POLY PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212332
            [companyName] => HAINAN POLY PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-12
        )

)