Details for New Drug Application (NDA): 211524
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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: 211524
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 211524 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1665 | 69238-1665-6 | 1 BOTTLE, DROPPER in 1 CARTON (69238-1665-6) / 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: | Mar 1, 2024 | TE: | AT | RLD: | No |
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