NDA 021317

BAYER

FDA Drug Application

Application #021317

Documents

• Letter: 2001-10-18
• Label: 2001-10-18
• Review: 2001-10-18

Application Sponsors

NDA 021317

BAYER

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN

ASPIRIN

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDA

ORIG

1

AP

2001-10-18

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

BAYER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21317
            [companyName] => BAYER
            [docInserts] => ["",""]
            [products] => [{"drugName":"BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN","activeIngredients":"ASPIRIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/18\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21317lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN","submission":"ASPIRIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2001-10-18
        )

)