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NY K80489




November 13, 2003
CLA-2-30:RR:NC:2:238 K80489

CATEGORY: CLASSIFICATION

TARIFF NO.: 3004.90.9110

Mr. David Walker
Daiichi Pharmaceutical Corporation
11 Philips Parkway
Montvale, NJ

RE: The tariff classification of FLOXIN® Otic (ofloxacin otic solution) 0.3%, imported put up in plastic multiple-dose bottles, from Finland

Dear Mr. Walker:

In your letter dated October 27, 2003 you requested a tariff classification ruling.

The subject product, FLOXIN® Otic (ofloxacin otic solution) 0.3%, is a topical anti-infective medicament containing the antibacterial drug Ofloxacin (0.3 mg/mL) as the active ingredient. FLOXIN® Otic is indicated for the treatment of infections of the ear canal and middle ear, and will be supplied put up in plastic multiple-dose bottles (5.0 mL and 10.0 mL per bottle).

The applicable subheading for the subject product will be 3004.90.9110, Harmonized Tariff Schedule of the United States (HTS), which provides for “Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses or in forms or packings for retail sale: Other: Other: Other: Anti-infective medicaments: Other.” The rate of duty will be free.

This merchandise may be subject to the requirements of the Federal Food, Drug, and Cosmetic Act, which is administered by the U.S. Food and Drug Administration. You may contact them at 5600 Fishers Lane, Rockville, Maryland 20857, telephone number 301-443-1544.

This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).

A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Harvey Kuperstein at 646-733-3033.

Sincerely,

Robert B. Swierupski

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