APPLICATION
ANDA206166
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-11
LATEST ACTION
2023-08-29
ROUTE
EPIDURAL, INFILTRATION, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) · SOLUTION · INJECTION
Approval history
2023-08-29Labeling · Supplement 10 · standardAP
2019-11-14Labeling · Supplement 3 · 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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