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Details for New Drug Application (NDA): 022548
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NDA 022548 describes ZYMAXID, which is a drug marketed by Allergan and is included in one NDA. It is available from two suppliers. Additional details are available on the ZYMAXID profile page.
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.
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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