Details for New Drug Application (NDA): 217903
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NDA 217903 describes OFLOXACIN, which is a drug marketed by Bedford, Altaire Pharms Inc, Alvogen, Amneal, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Caplin, Hikma, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-six NDAs. It is available from twenty-five 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. Twenty-six 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. Twenty-six suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 217903
| Tradename: | OFLOXACIN |
| Applicant: | Caplin |
| Ingredient: | ofloxacin |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217903
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 217903 | ANDA | Caplin Steriles Limited | 65145-143 | 65145-143-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-143-01) / 5 mL in 1 BOTTLE, DROPPER |
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 217903 | ANDA | Caplin Steriles Limited | 65145-144 | 65145-144-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-144-01) / 10 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 5, 2024 | TE: | AT | RLD: | No | ||||
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