ANDA 204797

EXELA PHARMA

FDA Drug Application

Application #204797

Application Sponsors

ANDA 204797

EXELA PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

6GM/30ML (200MG/ML)

0

ACETYLCYSTEINE

ACETYLCYSTEINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-04-15

STANDARD

Submissions Property Types

ORIG

1

Null

29

TE Codes

001

Prescription

AP

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204797
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)