Details for New Drug Application (NDA): 202653
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NDA 202653 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 202653
| Tradename: | GATIFLOXACIN |
| Applicant: | Lupin Ltd |
| Ingredient: | gatifloxacin |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
| Approval Date: | Aug 28, 2013 | TE: | AT | RLD: | No | ||||
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