Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206166
Company: INFORLIFE
Company: INFORLIFE
| 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 |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 500MG/100ML (5MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 1GM/200ML (5MG/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 |
|---|---|---|---|---|---|---|---|
| 06/11/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206166Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/29/2023 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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 | 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 PHARMA LTD |
| 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 PHARMA LTD |
| 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; 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 |