definiens: means : ( a ) in the case where the LicensedFormulation that has been granted MA Approval for an Indicated Disease is a fixed - dose combination, a proposedformulation of the Compound and sulindac as the active ingredients in a single fixed - dose combination wherein thedose of the Compound in the combination is 375 milligrams and the sulindac dose in the combination is 75 milligrams(or whole multiples of both in the same proportion ) ; or ( b ) a pharmaceutical formulation in the tablet, capsule, granularor powder form of the Compound that, with respect to tablet or capsule forms, is in any dose less than 1000 mg of theCompound or such form being a ½, a 1/3 or a whole number multiple of the dose of the Compound being used in arespective Licensed Product . For clarity, an oral liquid form of the Compound is not an Interchangeable Formulation