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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020533
Company: FRESENIUS KABI USA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAROPIN ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/100ML (2MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 400MG/200ML (2MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION;INJECTION Prescription AP Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription AP Yes Yes
NAROPIN ROPIVACAINE HYDROCHLORIDE 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INJECTION Discontinued None Yes No
NAROPIN ROPIVACAINE HYDROCHLORIDE 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION;INJECTION Discontinued None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
06/28/2022 SUPPL-44 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533Orig1s044lbl.pdf
06/15/2022 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533s038lbl.pdf
11/02/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf
12/26/2012 SUPPL-28 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s028lbl.pdf
11/09/2012 SUPPL-29 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s029lbl.pdf
02/19/2010 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf
02/19/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf
08/08/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020533s014lbl.pdf
08/11/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf
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