NDA 208791

B BRAUN MEDICAL INC

FDA Drug Application

Application #208791

Documents

• Label: 2017-09-28
• Letter: 2017-09-28
• Review: 2018-03-21

Application Sponsors

NDA 208791

B BRAUN MEDICAL INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRATHECAL

50MG/5ML (10MG/ML)

1

CLOROTEKAL

CHLOROPROCAINE HYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2017-09-26

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

B BRAUN MEDICAL INC

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            [supplements] => 
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        )

)