Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090318
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION | Discontinued | None | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION | Discontinued | None | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION | Discontinued | None | No | No |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/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 |
|---|---|---|---|---|---|---|---|
| 09/23/2014 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/23/2023 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/23/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |