← FDA DRUG APPROVALS

FDA ANDA · ANDA219883

ROPIVACAINE HYDROCHLORIDE

Sponsor: ANTHEA PHARMA

APPLICATION

ANDA219883

TYPE

ANDA

ORIGINAL APPROVAL

2025-03-21

LATEST ACTION

2025-03-21

ROUTE

EPIDURAL, INFILTRATION, PERINEURAL, INJECTION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

ROPIVACAINE HYDROCHLORIDEPrescription

ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) · SOLUTION · INJECTION

ROPIVACAINE HYDROCHLORIDEPrescription

ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) · SOLUTION · INJECTION

ROPIVACAINE HYDROCHLORIDEPrescription

ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) · SOLUTION · INJECTION

ROPIVACAINE HYDROCHLORIDEPrescription

ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) · SOLUTION · INJECTION

ROPIVACAINE HYDROCHLORIDEPrescription

ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) · SOLUTION · INJECTION

Approval history

2025-03-21UNKNOWN · Original · standardAP

VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →