The tariff classification of Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension 1%/0.2% vials in dosage form, from India

N298958 August 3, 2018 CLA-2-30:OT:RR:NC:N1:138 CATEGORY: Classification TARIFF NO.: 3004.90.9285 Mr. Satish Srinivasan Sentiss Pharmaceuticals LLC 197 Avenida de la Estrella San Clemente, CA 92672 RE: The tariff classification of Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension 1%/0.2% vials in dosage form, from India Dear Mr. Srinivasan: In your letter dated July 12, 2018, you requested a tariff classification ruling. Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension 1%/0.2% is a medicinal preparation containing a fixed combination of Brinzolamide (carbonic anhydrase inhibitor) and Brimonidine Tartrate (alpha 2 adrenergic receptor agonist), as the active ingredients. It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The applicable subheading for the Brinzolamide/Brimonidine Tartrate Ophthalmic Suspension 1%/0.2% vials in dosage form will be 3004.90.9285, Harmonized Tariff Schedule of the United States (HTSUS), which provides for "Medicaments (…) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (…) Other: Other: Other: Medicaments primarily affecting the eyes, ears or respiratory system: Other: Other.” The rate of duty will be free. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov. 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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division