Details for New Drug Application (NDA): 211525
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The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.
Summary for 211525
Tradename: | OFLOXACIN |
Applicant: | Amneal |
Ingredient: | ofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211525
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 211525 | ANDA | A-S Medication Solutions | 50090-5670 | 50090-5670-0 | 1 BOTTLE, DROPPER in 1 CARTON (50090-5670-0) / 5 mL in 1 BOTTLE, DROPPER |
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 211525 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1615 | 69238-1615-3 | 1 BOTTLE, DROPPER in 1 CARTON (69238-1615-3) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 0.3% | ||||
Approval Date: | Aug 30, 2019 | TE: | AT | RLD: | No |
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