← FDA DRUG APPROVALS
FDA ANDA · ANDA211188
STERILE WATER
sterile water for injection
Sponsor: MEDEFIL INC
APPLICATION
ANDA211188
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-02
LATEST ACTION
2020-08-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, N/A
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (10ML) · LIQUID · N/A
STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (3ML) · LIQUID · N/A
STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (1ML) · LIQUID · N/A
STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (5ML) · LIQUID · N/A
STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (2.5ML) · LIQUID · N/A
Approval history
2020-08-26Labeling · Supplement 2 · standardAP
2019-12-02UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.