Details for New Drug Application (NDA): 215886
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NDA 215886 describes OFLOXACIN, which is a drug marketed by Bedford, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Micro Labs, Sandoz, Sentiss, Somerset, Hikma, Somerset Theraps Llc, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in thirty NDAs. It is available from thirty suppliers. Additional details are available on the OFLOXACIN profile page.
The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 215886
| Tradename: | OFLOXACIN |
| Applicant: | Mankind Pharma |
| Ingredient: | ofloxacin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215886
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 215886 | ANDA | Major Pharmaceuticals | 0904-7434 | 0904-7434-05 | 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-05) / 5 mL in 1 BOTTLE, DROPPER |
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 215886 | ANDA | Major Pharmaceuticals | 0904-7434 | 0904-7434-10 | 1 BOTTLE, DROPPER in 1 CARTON (0904-7434-10) / 10 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | Nov 23, 2022 | TE: | AT | RLD: | No | ||||
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