ANDA 075702

BAUSCH AND LOMB

FDA Drug Application

Application #075702

Documents

• Label: 2001-07-03
• Review: 2001-07-03
• Letter: 2001-07-03

Application Sponsors

ANDA 075702

BAUSCH AND LOMB

Marketing Status

• Over-the-counter: 001

Application Products

001

SPRAY, METERED;NASAL

5.2MG/SPRAY

0

CROMOLYN SODIUM

CROMOLYN SODIUM

FDA Submissions

ORIG

1

AP

2001-07-03

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75702
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROMOLYN SODIUM","activeIngredients":"CROMOLYN SODIUM","strength":"5.2MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/03\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2001\\\/75-702_Cromolyn%20Sodium_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CROMOLYN SODIUM","submission":"CROMOLYN SODIUM","actionType":"5.2MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-07-03
        )

)