Details for New Drug Application (NDA): 213542
✉ Email this page to a colleague
NDA 213542 describes GATIFLOXACIN, which is a drug marketed by Apotex Inc, Caplin, Hikma, Lupin Ltd, Rising, and Sandoz, and is included in six NDAs. It is available from three suppliers. 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.
Summary for 213542
| Tradename: | GATIFLOXACIN |
| Applicant: | Caplin |
| Ingredient: | gatifloxacin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213542
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 213542 | ANDA | Caplin Steriles Limited | 65145-207 | 65145-207-01 | 1 BOTTLE in 1 CARTON (65145-207-01) / 2.5 mL in 1 BOTTLE |
| GATIFLOXACIN | gatifloxacin | SOLUTION/DROPS;OPHTHALMIC | 213542 | ANDA | Leading Pharma, LLC | 69315-331 | 69315-331-02 | 2.5 mL in 1 BOTTLE (69315-331-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Nov 3, 2021 | TE: | AT | RLD: | No | ||||
Complete Access Available with Subscription
