FdaApplication
NDA 020533
Identifiers
- fda_app_no: NDA020533
Properties
| Property | Value |
|---|---|
| applicant_name | FRESENIUS KABI USA LLC |
| application_type | NDA |
| approval_date | 1996-09-24 |
Products (13)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION |
| 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ROPIVACAINE HYDROCHLORIDE | 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 500MG/100ML (5MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 1GM/200ML (5MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 200MG/100ML (2MG/ML) | SOLUTION;INJECTION |
| NAROPIN | ROPIVACAINE HYDROCHLORIDE | 400MG/200ML (2MG/ML) | SOLUTION;INJECTION |
13 products