FdaApplication
ANDA 217803
Identifiers
- fda_app_no: ANDA217803
Properties
| Property | Value |
|---|---|
| applicant_name | AMNEAL EU LTD |
| application_type | ANDA |
| approval_date | 2025-10-29 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS;OTIC |
1 product