ANDA 210773

HQ SPCLT PHARMA

FDA Drug Application

Application #210773

Application Sponsors

ANDA 210773

HQ SPCLT PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	500MG/VIAL	0	MEROPENEM	MEROPENEM
002	INJECTABLE;INJECTION	1GM/VIAL	0	MEROPENEM	MEROPENEM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-08-16

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

HQ SPCLT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210773
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MEROPENEM","activeIngredients":"MEROPENEM","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-08-16
        )

)