Details for New Drug Application (NDA): 076407
✉ 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-nine suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 076407
Tradename: | OFLOXACIN |
Applicant: | Sentiss |
Ingredient: | ofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076407
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 076407 | ANDA | Proficient Rx LP | 63187-662 | 63187-662-05 | 1 BOTTLE, DROPPER in 1 CARTON (63187-662-05) / 5 mL in 1 BOTTLE, DROPPER |
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 076407 | ANDA | Proficient Rx LP | 63187-662 | 63187-662-10 | 1 BOTTLE, DROPPER in 1 CARTON (63187-662-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
Approval Date: | Apr 15, 2008 | TE: | AT | RLD: | No |
Complete Access Available with Subscription