ANDA 207594

HQ SPCLT PHARMA

FDA Drug Application

Application #207594

Application Sponsors

ANDA 207594

HQ SPCLT PHARMA

Marketing Status

• Prescription: 001

Application Products

001

POWDER;INTRAVENOUS

EQ 500MG BASE/VIAL;500MG/VIAL

0

IMIPENEM AND CILASTATIN

CILASTATIN SODIUM; IMIPENEM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

HQ SPCLT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207594
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIPENEM AND CILASTATIN","activeIngredients":"CILASTATIN SODIUM; IMIPENEM","strength":"EQ 500MG BASE\/VIAL;500MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-12
        )

)