HUMANWELL PURACAP FDA Approval ANDA 214378

ANDA 214378

HUMANWELL PURACAP

FDA Drug Application

Application #214378

Application Sponsors

ANDA 214378HUMANWELL PURACAP

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

002TABLET; ORALEQ 75MG BASE || EQ 100MG BASE0TAPENTADOL HYDROCHLORIDETAPENTADOL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-04-28STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214378
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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