Request to Declare Sodium Chloride 23.4% Injection USP, 100mL fill in 100 cc and 200mL fill in cc Plastic Pharmacy Bulk Package Vitals are Suitable as as ANDA; CLOSED | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2018-P-4281

Request to Declare Sodium Chloride 23.4% Injection USP, 100mL fill in 100 cc and 200mL fill in cc Plastic Pharmacy Bulk Package Vitals are Suitable as as ANDA; CLOSED

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensNov 8, 2018

Comment Period ClosesFeb 7, 2019

Documents

Type	Title	Posted	Comments	Status
Other	Updated Final Response Letter from FDA CDER to Fresenius Kabi USA, LLC	Jul 9, 2026	--

Comment Statistics

Total Comments

Keywords

Suitability

Sodium Chloride

Pharmacy Bulk Package

23.4% Injection

100mL

200mL

100cc

200cc

ANDA

Data from Regulations.gov