Application 050356
- Type
- NDA
- Sponsor
- ENDO PHARMS INC
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLY-MYCIN S | COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | SUSPENSION/DROPS;OTIC | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63481-421 | Coly-Mycin S | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-421 | Coly-Mycin S | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-529 | Cortisporin TC | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals, Inc. | NDA | Current |