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
🏛 Food and Drug Administration (FDA)FDA-2018-P-4281
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Closed
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
OtherJul 9, 2026
Updated Final Response Letter from FDA CDER to Fresenius Kabi USA, LLCNo comment period
- Other· Nov 8, 2018Closed on Feb 7, 2019