Details for New Drug Application (NDA): 216130
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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.
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 | RPK Pharmaceuticals, Inc. | 53002-6604 | 53002-6604-1 | 5 mL in 1 BOTTLE, DROPPER (53002-6604-1) |
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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