Details for New Drug Application (NDA): 204227
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NDA 204227 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, and Torrent, and is included in six NDAs. It is available from one supplier. Additional details are available on the GATIFLOXACIN profile page.
The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 204227
| Tradename: | GATIFLOXACIN |
| Applicant: | Sandoz |
| Ingredient: | gatifloxacin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204227
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 204227 | ANDA | Sandoz Inc | 61314-672 | 61314-672-25 | 1 BOTTLE, DROPPER in 1 CARTON (61314-672-25) / 2.5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Jul 11, 2016 | TE: | AT | RLD: | No | ||||
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