APPLICATION
ANDA203955
TYPE
ANDA
ORIGINAL APPROVAL
2016-04-11
LATEST ACTION
2025-08-06
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) · SOLUTION · INJECTION
Approval history
2025-08-06Labeling · Supplement 2 · standardAP
2025-08-06Labeling · Supplement 8 · 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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