| Product Information |
|
| Registration Number |
DRP-9729-01
|
| Generic Name |
Fluocinolone Acetonide + Polymyxin B Sulfate + Neomycin Sulfate
|
| Brand Name |
Otowell
|
| Dosage Strength |
250 mcg/10,000 U/3.5 mg per mL
|
| Dosage Form |
Otic Solution
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Plastic Bottle x 5mL (Box of 1's)
|
| Pharmacologic Category |
Corticosteroid and Anti-infective
|
| Manufacturer |
Pascual Laboratories, Inc
|
| Country of Origin |
Philippines
|
| Trader |
ADP Pharma Corporation
|
| Importer |
|
| Distributor |
Seville Pharmaceuticals, Inc.
|
| Application Type |
CLIDP Conversion
|
| Issuance Date |
04 May 2023
|
| Expiry Date |
30 July 2027
|