ANDA 201751

HANSAMED INC

FDA Drug Application

Application #201751

Documents

• Label: 2017-07-11
• Letter: 2017-07-13

Application Sponsors

ANDA 201751

HANSAMED INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

4%;EQ 0.0085MG BASE/1.7ML (4%; EQ 0.005MG BASE/ML)

0

ULTACAN

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

FDA Submissions

ORIG

1

AP

2017-07-11

Submissions Property Types

ORIG

1

Null

15

CDER Filings

HANSAMED INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201751
            [companyName] => HANSAMED INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTACAN","activeIngredients":"ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE","strength":"4%;EQ 0.0085MG BASE\/1.7ML (4%; EQ 0.005MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/11\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201751Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201751Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201751Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-07-11
        )

)