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Details for New Drug Application (NDA): 021571

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NDA 021571 describes IQUIX, which is a drug marketed by Santen and is included in one NDA. It is available from one supplier. Additional details are available on the IQUIX profile page.

The generic ingredient in IQUIX is levofloxacin. There are twenty-eight drug master file entries for this compound. Sixty suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the levofloxacin profile page.

Summary for NDA: 021571

Tradename:
IQUIX
Applicant:
Santen
Ingredient:
levofloxacin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 021571

Ingredient-typeQuinolones

Suppliers and Packaging for NDA: 021571

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IQUIX
levofloxacin
SOLUTION/DROPS;OPHTHALMIC 021571 NDA Vistakon Pharmaceuticals LLC 68669-145 68669-145-05 5 mL in 1 BOTTLE (68669-145-05)
IQUIX
levofloxacin
SOLUTION/DROPS;OPHTHALMIC 021571 NDA Vistakon Pharmaceuticals LLC 68669-145 68669-145-99 1 mL in 1 BOTTLE (68669-145-99)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 1, 2004TE:RLD:No

Expired Orange Book Patents for NDA: 021571

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santen
IQUIX
levofloxacin
SOLUTION/DROPS;OPHTHALMIC021571-001Mar 1, 20045,053,407► subscribe
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