Application 204636
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 200MG/100ML (2MG/ML) | No | No |
| 002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | SOLUTION;INJECTION | 400MG/200ML (2MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 17478-082 | Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | Akorn | ANDA | Current |
| 17478-082 | Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | Akorn | ANDA | Current |
| 17478-082 | Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | Akorn, Inc. | ANDA | Current |
| 17478-082 | Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | Akorn, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53057 | ORIG | 2018-04-05 |