Details for New Drug Application (NDA): 202692
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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.
Summary for 202692
Tradename: | OFLOXACIN |
Applicant: | Altaire Pharms Inc |
Ingredient: | ofloxacin |
Patents: | 0 |
Suppliers and Packaging for NDA: 202692
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OFLOXACIN | ofloxacin | SOLUTION/DROPS;OPHTHALMIC | 202692 | ANDA | Altaire Pharmaceuticals Inc. | 59390-140 | 59390-140-05 | 5 mL in 1 BOTTLE, DROPPER (59390-140-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.3% | ||||
Approval Date: | Apr 29, 2013 | TE: | AT | RLD: | No |
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