← FDA DRUG APPROVALS

FDA ANDA · ANDA211222

STERILE WATER

Sponsor: NEPHRON

APPLICATION
ANDA211222
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-10
LATEST ACTION
2021-02-10
ROUTE
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, N/A
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription

Products

STERILE WATER FOR INJECTIONPrescription
STERILE WATER FOR INJECTION 100% (5ML) · LIQUID · N/A

Approval history

2021-02-10UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →