FdaApplication
ANDA 207636
Identifiers
- fda_app_no: ANDA207636
Properties
| Property | Value |
|---|---|
| applicant_name | SOMERSET THERAPEUTICS LLC |
| application_type | ANDA |
| approval_date | 2018-06-15 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/20ML (5MG/ML) | SOLUTION;INJECTION |
| ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION;INJECTION |
7 products