SPL Set ID: 806e8d0f-ff42-4d6e-b840-49e3bf867cb5

1 drug(s) with this SPL Set ID

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Olopatadine Hydrochloride OLOPATADINE HYDROCHLORIDE
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Olopatadine HCl nasal spray, 665 mcg is a metered-spray solution for nasal administration. Olopatadine hydrochloride USP, the active component of olopatadine HCl nasal spray, 665 mcg, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride, USP is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz [b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88 g/mol, and its molecular formula is C 21 H 23 NO 3 •HCl with the following chemical structure: Olopatadine HCl nasal spray, 665 mcg contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride USP, which is equivalent to 600 mcg of olopatadine (base) [see Dosage Forms and Strengths (3) ] . Olopatadine HCl nasal spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate (anhydrous), edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. Structural Formula

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