Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020533
Company: FRESENIUS KABI USA
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ROPIVACAINE HYDROCHLORIDE | 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION | Discontinued | None | Yes | No |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| ROPIVACAINE HYDROCHLORIDE | 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION | Discontinued | None | Yes | No |
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 |
|---|---|---|---|---|---|
| 06/28/2022 | SUPPL-44 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020533Orig1s044ltr.pdf | |
| 06/15/2022 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020533s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020533Orig1s038ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 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 |
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 | 218713 | KINDOS |
| 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 | 219883 | ANTHEA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 212808 | CAPLIN |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 205612 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 214074 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 | 212808 | CAPLIN |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 205612 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 214074 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 | 216605 | AMNEAL |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 212808 | CAPLIN |
| 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 |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 211907 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206166 | INFORLIFE |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206091 | MYLAN LABS LTD |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 204636 | RISING |
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 | 216605 | AMNEAL |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 212808 | CAPLIN |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 210102 | GLAND |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 211907 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206166 | INFORLIFE |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 206091 | MYLAN LABS LTD |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 204636 | RISING |
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 | 219883 | ANTHEA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 212808 | CAPLIN |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 205612 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 214074 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 | 203955 | RISING |
| 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 | 216605 | AMNEAL |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 500MG/100ML (5MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 211907 | HIKMA |
| 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 | 216605 | AMNEAL |
| 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 | 219883 | ANTHEA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 212808 | CAPLIN |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 205612 | EUGIA PHARMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 214074 | HIKMA |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION | Prescription | No | AP | 218713 | KINDOS |
| 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 |