Initial Product ANDA definition

Initial Product ANDA means ANDA #76-429 for the Initial Product filed with the FDA in the United States, and all supplements and amendments thereto.
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Examples of Initial Product ANDA in a sentence

  • Subject to the terms and conditions of this Agreement, as of the Effective Date, Athlon hereby sells, transfers, conveys, assigns and delivers to AAI, free and clear from all Encumbrances, and AAI hereby purchases, acquires and accepts from Athlon, all of Athlon's right, title and interest, as of the Effective Date, in and to the Purchased Assets in existence as of the Effective Date (including the Initial Product ANDA even though not approved by the FDA).

  • In the event the FDA approves ANDA #76-429 (the "Initial Product ANDA"), AAI will promote the AAI Product referenced in the Initial Product ANDA (the "Initial Product") during the Services Period and will not substitute other AAI Products for Initial Product under the this Agreement during the Services Period, except as agreed by AAI and Athlon.

Related to Initial Product ANDA

  • Commercial Product means any such product as defined in FAR 2.101.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate):