APPLICATION
ANDA204636
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-16
LATEST ACTION
2025-03-20
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) · SOLUTION · INJECTION
Approval history
2025-03-20Labeling · Supplement 10 · 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.
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