ANDA 040277

AKORN INC

FDA Drug Application

Application #040277

Documents

• Letter: 2000-03-16
• Label: 2004-06-14
• Review: 2003-07-31

Application Sponsors

ANDA 040277

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

PROPARACAINE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2000-03-16

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AT

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40277
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPARACAINE HYDROCHLORIDE","activeIngredients":"PROPARACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/16\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/40277_Proparacaine%20Hydrochloride%20Ophthalmic_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PROPARACAINE HYDROCHLORIDE","submission":"PROPARACAINE HYDROCHLORIDE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-03-16
        )

)