Details for New Drug Application (NDA): 216130
NDA 216130 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, Bausch And Lomb Inc, 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-one suppliers. Additional details are available on the OFLOXACIN profile page.
The generic ingredient in OFLOXACIN is ofloxacin. There is one drug master file entry for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
The generic ingredient in OFLOXACIN is ofloxacin. There is one drug master file entry for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 216130
| Tradename: | OFLOXACIN |
| Applicant: | Mankind Pharma |
| Ingredient: | ofloxacin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216130
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 216130 | ANDA | A-S Medication Solutions | 50090-7207 | 50090-7207-0 | 5 mL in 1 BOTTLE, DROPPER (50090-7207-0) |
| OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 216130 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3604 | 68071-3604-3 | 10 mL in 1 BOTTLE, DROPPER (68071-3604-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 0.3% | ||||
| Approval Date: | Jul 14, 2022 | TE: | AT | RLD: | No | ||||
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