ANDA 216591

ASPIRO

FDA Drug Application

Application #216591

Application Sponsors

ANDA 216591

ASPIRO

Marketing Status

• Prescription: 001
• Prescription: 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

2022-07-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

ASPIRO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216591
            [companyName] => ASPIRO
            [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":"07\/06\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-06
        )

)