SPL Set ID: 3ef0cff8-19c1-4441-b780-fca6c7ee1615

ABSORICA ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems: •10 mg – iron oxide (yellow) and titanium dioxide; •20 mg – iron oxide (red), and titanium dioxide; •25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14) ] , FD&C Yellow #6 and titanium dioxide; •30 mg – iron oxide (black, red and yellow) and titanium dioxide; •35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide; •40 mg – iron oxide (black, red and yellow) and titanium dioxide. ABSORICA LD ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, USP each capsule contains the following inactive ingredients: butylated hydroxy anisole, gelatin, hard gelatin capsule shell, polysorbate 80 and soybean oil. The gelatin capsules contain the following dye systems: •8 mg – D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and titanium dioxide •16 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide •20 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide •24 mg – D&C Yellow #10, FD&C Yellow #6 and titanium dioxide •28 mg – FD&C Blue #1, FD&C Red #40, and titanium dioxide •32 mg – ferrosoferric oxide, ferric oxide (red and yellow) and titanium dioxide The imprinting ink of 8 mg, 16 mg, 24 mg and 32 mg capsules contain the following ingredients: potassium hydroxide, propylene glycol, shellac and titanium dioxide. The imprinting ink of 20 mg and 28 mg capsules contain the following ingredients: ferrosoferric oxide, propylene glycol and shellac glaze. Isotretinoin Chemically, isotretinoin is 13- cis -retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder with a molecular weight of 300.44. It is practically insoluble in water, soluble in chloroform and sparingly soluble in alcohol and in isopropyl alcohol. The structural formula is: ABSORICA meets USP Dissolution Test 3. For ABSORICA LD, FDA approved dissolution test differs from the USP. spl-absorica-str.jpg