Details for New Drug Application (NDA): 215038
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NDA 215038 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, 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 twenty-nine 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.
Suppliers and Packaging for NDA: 215038
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 215038 | ANDA | Rising Pharma Holdings, Inc. | 64980-432 | 64980-432-01 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-01) / 10 mL in 1 BOTTLE, DROPPER |
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 215038 | ANDA | Rising Pharma Holdings, Inc. | 64980-432 | 64980-432-05 | 1 BOTTLE, DROPPER in 1 CARTON (64980-432-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 0.3% | ||||
| Approval Date: | Jan 19, 2022 | TE: | AT | RLD: | No | ||||
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