Details for New Drug Application (NDA): 076616
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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 076616
Tradename: | OFLOXACIN |
Applicant: | Hikma |
Ingredient: | ofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076616
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 076616 | ANDA | RPK Pharmaceuticals, Inc. | 53002-5604 | 53002-5604-1 | 1 BOTTLE in 1 CARTON (53002-5604-1) / 5 mL in 1 BOTTLE |
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OTIC | 076616 | ANDA | Proficient Rx LP | 71205-682 | 71205-682-05 | 1 BOTTLE in 1 CARTON (71205-682-05) / 5 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OTIC | Strength | 0.3% | ||||
Approval Date: | Mar 17, 2008 | TE: | AT | RLD: | No |
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