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FDA ANDA · ANDA212808

ROPIVACAINE HYDROCHLORIDE

Sponsor: CAPLIN

APPLICATION
ANDA212808
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-09
LATEST ACTION
2024-01-02
ROUTE
EPIDURAL, INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) · SOLUTION · INJECTION

Approval history

2024-01-02Labeling · Supplement 6 · standardAP
2023-12-21Manufacturing (CMC) · Supplement 7 · unknownTA
2020-04-09UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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