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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204636
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription AP No No
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription AP 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
03/16/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204636Orig1s000ltr.pdf

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION; 200MG/100ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 204636 AKORN
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 205612 EUGIA PHARMA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 210102 GLAND PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 206166 INFORLIFE

SOLUTION;INJECTION; 400MG/200ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 204636 AKORN
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 210102 GLAND PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 206166 INFORLIFE
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