NDA 205703

HQ SPCLT PHARMA

FDA Drug Application

Application #205703

Documents

• Letter: 2014-04-16
• Letter: 2016-04-11
• Label: 2016-04-08
• Review: 2016-10-20
• Summary Review: 2016-10-20

Application Sponsors

NDA 205703

HQ SPCLT PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	2.5GM/250ML (10MG/ML)	1	ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE
002	SOLUTION;INTRAVENOUS	2GM/100ML (20MG/ML)	1	ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER	ESMOLOL HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2016-04-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HQ SPCLT PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205703
            [companyName] => HQ SPCLT PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"2GM\/100ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER","activeIngredients":"ESMOLOL HYDROCHLORIDE","strength":"2.5GM\/250ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/07\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205703s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205703s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205703Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205703Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205703Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205703Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-04-07
        )

)