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Details for New Drug Application (NDA): 022548
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The generic ingredient in ZYMAXID is gatifloxacin. There are sixteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 022548
Tradename: | ZYMAXID |
Applicant: | Allergan |
Ingredient: | gatifloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022548
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZYMAXID | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 022548 | NDA | Allergan, Inc. | 0023-3615 | 0023-3615-01 | 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) > 1 mL in 1 BOTTLE, DROPPER |
ZYMAXID | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 022548 | NDA | Allergan, Inc. | 0023-3615 | 0023-3615-25 | 1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) > 2.5 mL in 1 BOTTLE, DROPPER |
Paragraph IV (Patent) Challenges for 022548
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ZYMAXID | SOLUTION/DROPS;OPHTHALMIC | gatifloxacin | 022548 | 2010-12-07 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | May 18, 2010 | TE: | AT | RLD: | Yes |
Expired US Patents for NDA 022548
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | ZYMAXID | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 022548-001 | May 18, 2010 | Start Trial | Start Trial |
Allergan | ZYMAXID | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 022548-001 | May 18, 2010 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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