ANDA 091193

EMERALD INTL LTD

FDA Drug Application

Application #091193

Application Sponsors

ANDA 091193

EMERALD INTL LTD

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INTRATHECAL	0.05MG/ML	0	BACLOFEN	BACLOFEN
002	INJECTABLE;INTRATHECAL	0.5MG/ML	0	BACLOFEN	BACLOFEN
003	INJECTABLE;INTRATHECAL	2MG/ML	0	BACLOFEN	BACLOFEN

FDA Submissions

ORIG

1

AP

2016-05-03

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

EMERALD INTL LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91193
            [companyName] => EMERALD INTL LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"0.05MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"0.5MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"BACLOFEN","activeIngredients":"BACLOFEN","strength":"2MG\/ML","dosageForm":"INJECTABLE;INTRATHECAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"0.05MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"0.5MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"BACLOFEN","submission":"BACLOFEN","actionType":"2MG\/ML","submissionClassification":"INJECTABLE;INTRATHECAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)