Details for New Drug Application (NDA): 022428
✉ Email this page to a colleague
NDA 022428 describes MOXEZA, which is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOXEZA profile page.
The generic ingredient in MOXEZA is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
The generic ingredient in MOXEZA is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 022428
| Tradename: | MOXEZA |
| Applicant: | Harrow Eye |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 19, 2010 | TE: | RLD: | Yes | |||||
| Patent: | 8,450,311 | Patent Expiration: | May 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 9,114,168 | Patent Expiration: | May 29, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
