APPLICATION
ANDA090318
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-23
LATEST ACTION
2023-07-23
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ROPIVACAINE HYDROCHLORIDEDiscontinued
ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEDiscontinued
ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEDiscontinued
ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) · SOLUTION · INJECTION
ROPIVACAINE HYDROCHLORIDEDiscontinued
ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) · SOLUTION · INJECTION
Approval history
2023-07-23Labeling · Supplement 7 · standardAP
2023-07-23Labeling · Supplement 5 · standardAP
2014-09-23OriginalAP
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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