Application 062721
- Type
- ANDA
- Sponsor
- ALCON PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE | DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | SUSPENSION/DROPS;OPHTHALMIC | 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-595 | Neomycin and Polymyxin B Sulfates and Dexamethasone | neomycin sulfate, polymyxin B sulfate and dexamethasone | Rebel Distributors Corp | ANDA | Current |