Details for New Drug Application (NDA): 217904
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The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Suppliers and Packaging for NDA: 217904
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 217904 | ANDA | Caplin Steriles Limited | 65145-141 | 65145-141-01 | 5 mL in 1 BOTTLE, DROPPER (65145-141-01) |
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 217904 | ANDA | Caplin Steriles Limited | 65145-142 | 65145-142-01 | 10 mL in 1 BOTTLE, DROPPER (65145-142-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
Approval Date: | Apr 12, 2024 | TE: | AT | RLD: | No |
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