Purepac ANDA means ANDA No. 76-450, metformin extended release 500-mg tablets.
Examples of Purepac ANDA in a sentence
New in 2021: Our Cafeteria 125 Vendor will be Sterling, effective October 1, 2021 (instead of Basic).
New in 2021: Our Cafeteria 125 Vendor will be Sterling, effective October 1, 2021 (instead of Basic).
ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.
PMA means the annual product multiplier and/or seasonal factor as appropriate for Gas Year “t”, in accordance with the Gas Product Multipliers and Time Factors Table.
ONYX means Onyx Acceptance Corporation, and its successors.
MFDA means the Mutual Fund Dealers Association of Canada;
API means the American Petroleum Institute.
mg means milligram.
FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.
Distillery manufacturing license means a license issued in accordance with
NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.
Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.
Epinephrine auto-injector means a device for immediate self-administration or administration by another trained person of a measured dose of epinephrine to a person at risk of anaphylaxis.
Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.
Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”
Finished Product means a cannabis product in its final form to be sold at a retail premises.
Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).
FDA means the United States Food and Drug Administration and any successor agency thereto.
in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
Novartis shall have the meaning set forth in the Preamble.
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.
Drug Product means a specific drug in dosage form from a known source of manufacture, whether
Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.
Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
Medical cannabis card means the same as that term is defined in Section 26-61a-102.
Product means any deliverable under the Contract, which may include commodities, services, technology or software.