Application 216007
- Type
- ANDA
- Sponsor
- CHENGDU SHUODE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NALMEFENE HYDROCHLORIDE | NALMEFENE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) | No | Yes |
| 002 | NALMEFENE HYDROCHLORIDE | NALMEFENE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) | No | No |
| 003 | NALMEFENE HYDROCHLORIDE | NALMEFENE HYDROCHLORIDE | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 2MG BASE/2ML (EQ 1MGBASE/ML) | No | No |