Drugs@FDA: FDA Approved Drug Products

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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) SOLUTION;INJECTION Discontinued None No No
NAROPIN ROPIVACAINE HYDROCHLORIDE 50MG/10ML (5MG/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
09/24/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020533Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020533Orig1s035ltr.pdf
02/15/2018 SUPPL-34 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020533Orig1s034ltr.pdf
06/06/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/16/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/09/2012 SUPPL-29 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s029lbl.pdf
12/26/2012 SUPPL-28 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020533s028lbl.pdf
11/15/2012 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/29/2014 SUPPL-26 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020533Orig1s026ltr.pdf
04/21/2013 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/19/2010 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf
02/19/2010 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020533s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020533s020s021ltr.pdf
08/08/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020533s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020533s014LTR.pdf
08/11/2004 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20533s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20533s012ltr.pdf
07/17/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/09/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/2000 SUPPL-5 Labeling

Label is not available on this site.

11/02/2000 SUPPL-2 Efficacy-New Dosing Regimen Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-533s002_Naropin.cfm
05/01/1998 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

NAROPIN

SOLUTION;INJECTION; 20MG/10ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 20MG/10ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 40MG/20ML (2MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 090318 MYLAN ASI
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 40MG/20ML (2MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 100MG/20ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/20ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 150MG/20ML (7.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 090318 MYLAN ASI
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/20ML (7.5MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 100MG/10ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 100MG/10ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

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 AUROBINDO 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 206166 INFORLIFE

SOLUTION;INJECTION; 150MG/30ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 203955 AKORN INC
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 090318 MYLAN ASI
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 078601 NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 150MG/30ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

SOLUTION;INJECTION; 500MG/100ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 500MG/100ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 206166 INFORLIFE

SOLUTION;INJECTION; 1GM/200ML (5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 1GM/200ML (5MG/ML) SOLUTION;INJECTION Prescription No AP 206166 INFORLIFE

SOLUTION;INJECTION; 200MG/20ML (10MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NAROPIN ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription Yes AP 020533 FRESENIUS KABI USA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 205612 AUROBINDO PHARMA LTD
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 090194 HOSPIRA
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 090318 MYLAN ASI
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 078601 NAVINTA LLC
ROPIVACAINE HYDROCHLORIDE ROPIVACAINE HYDROCHLORIDE 200MG/20ML (10MG/ML) SOLUTION;INJECTION Prescription No AP 207636 SOMERSET THERAPS LLC

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