definiens: shall mean those pharmaceutical products approved for marketing in the United Statespursuant to the following NDAs and ANDAs in each case including the specified active pharmaceutical ingredient as the soleactive pharmaceutical ingredient and in the dosage strength(s ), formulation(s ) and packaging designated in the respective NDAand ANDA as approved on the date hereof and as set forth on Schedule 1.01(lll ): ( i ) diltiazem approved pursuant to NDA 20 - 401(including Product sold under the Tiazac(R ) trademark ), ( ii ) rimantadine approved in tablet form pursuant to NDA 19 - 649(including Product sold under the Flumadine(R ) trademark ), ( iii ) theophylline approved in elixir form pursuant to ANDA 85 - 186(including Product sold under the Elixophyllin(R ) trademark ), ( iv ) theophylline approved in a tablet form pursuant to ANDAs 87 - 400, 88 - 320 and 88 - 321 ( including Product sold under the Theochron(R ) trademark ) and ( v ) isosorbide dinitrate approved formarketing pursuant to ANDA 40 - 009 ( including Product sold under the Isochron(R ) trademark )