Application 060582
- Type
- ANDA
- Sponsor
- MONARCH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEOSPORIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SOLUTION/DROPS;OPHTHALMIC | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | No | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42757 | ORIG | 1955-04-11 |