Details for New Drug Application (NDA): 215038
✉ Email this page to a colleague
The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 215038
Tradename: | OFLOXACIN |
Applicant: | Fdc Ltd |
Ingredient: | ofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 215038
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 215038 | ANDA | Rising Pharmaceuticals, Inc. | 64980-432 | 64980-432-01 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER |
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 215038 | ANDA | Rising Pharmaceuticals, Inc. | 64980-432 | 64980-432-05 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OTIC | Strength | 0.3% | ||||
Approval Date: | Jan 19, 2022 | TE: | RLD: | No |
Complete Access Available with Subscription