ANDA 214378

HUMANWELL PURACAP

FDA Drug Application

Application #214378

Application Sponsors

ANDA 214378

HUMANWELL PURACAP

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

TABLET; ORAL

EQ 75MG BASE || EQ 100MG BASE

0

TAPENTADOL HYDROCHLORIDE

TAPENTADOL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-04-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

Accessdata Error

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

)