ANDA 207101

BAXTER HLTHCARE CORP

FDA Drug Application

Application #207101

Application Sponsors

ANDA 207101

BAXTER HLTHCARE CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

EQ 6MG BASE/0.5ML EQ 12MG BASE/ML

0

SUMATRIPTAN SUCCINATE

SUMATRIPTAN SUCCINATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2023-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207101
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 6MG BASE\/0.5ML EQ 12MG BASE\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-19
        )

)