Application 060707
- Type
- ANDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEOSPORIN G.U. IRRIGANT | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SOLUTION;IRRIGATION | EQ 40MG BASE/ML;200,000 UNITS/ML | No | Yes |
| 002 | NEOSPORIN G.U. IRRIGANT | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SOLUTION; IRRIGATION | EQ 800MG BASE/20ML;4,000,000 UNITS/20ML (EQ 40MG BASE/ML;200,000 UNITS/ML) | Yes | No |