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FDA ANDA · ANDA207636

ROPIVACAINE HYDROCHLORIDE

Sponsor: SOMERSET THERAPS LLC

APPLICATION
ANDA207636
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-15
LATEST ACTION
2022-11-04
ROUTE
EPIDURAL, INFILTRATION, PERINEURAL, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/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 200MG/20ML (10MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEPrescription
ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) · SOLUTION · INJECTION

Approval history

2022-11-04Labeling · Supplement 3 · standardAP
2022-11-04Labeling · Supplement 1 · standardAP
2022-11-04Labeling · Supplement 10 · standardAP
2022-11-04Labeling · Supplement 4 · standardAP
2018-06-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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