Details for New Drug Application (NDA): 021598
✉ Email this page to a colleague
NDA 021598 describes VIGAMOX, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers. Additional details are available on the VIGAMOX profile page.
The generic ingredient in VIGAMOX 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 VIGAMOX 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 021598
| Tradename: | VIGAMOX |
| Applicant: | Harrow Eye |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 021598
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIGAMOX | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021598 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-7135 | 0781-7135-93 | 1 BOTTLE, PLASTIC in 1 CARTON (0781-7135-93) / 3 mL in 1 BOTTLE, PLASTIC |
| VIGAMOX | moxifloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021598 | NDA | Harrow Eye, LLC | 82667-700 | 82667-700-03 | 1 BOTTLE in 1 CARTON (82667-700-03) / 3 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | EQ 0.5% BASE | ||||
| Approval Date: | Apr 15, 2003 | TE: | AT1 | RLD: | Yes | ||||
Complete Access Available with Subscription
