Details for New Drug Application (NDA): 076513
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NDA 076513 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, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Ltd, Ranbaxy Labs Ltd, and Teva, and is included in twenty-eight 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 076513
| Tradename: | OFLOXACIN |
| Applicant: | Apotex Inc |
| Ingredient: | ofloxacin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 076513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 076513 | ANDA | A-S Medication Solutions | 50090-5186 | 50090-5186-0 | 1 BOTTLE, DROPPER in 1 CARTON (50090-5186-0) / 10 mL in 1 BOTTLE, DROPPER |
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 076513 | ANDA | A-S Medication Solutions | 50090-5209 | 50090-5209-0 | 1 BOTTLE, DROPPER in 1 CARTON (50090-5209-0) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
| Approval Date: | May 14, 2004 | TE: | AT | RLD: | No | ||||
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