Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090318
Company: MYLAN ASI
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Discontinued None No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/23/2014 ORIG-1 Approval

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