UNICHEM FDA Approval ANDA 213301

ANDA 213301

UNICHEM

FDA Drug Application

Application #213301

Application Sponsors

ANDA 213301UNICHEM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL50MG0CELECOXIBCELECOXIB
002CAPSULE;ORAL100MG0CELECOXIBCELECOXIB
003CAPSULE;ORAL200MG0CELECOXIBCELECOXIB
004CAPSULE;ORAL400MG0CELECOXIBCELECOXIB

FDA Submissions

UNKNOWN; ORIG1AP2021-01-14STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213301
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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