Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 090194
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Prescription | AP | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/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 |
|---|---|---|---|---|---|---|---|
| 09/23/2014 | ORIG-1 | Approval |
Label is not available on this site. |
ROPIVACAINE HYDROCHLORIDE
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; 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; 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; 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; 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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