Relevant ANDA definition

Relevant ANDA means an Abbreviated New Drug Application in the U.S. in relation to a Licensed Product submitted to the FDA by the Licensee under section 505(j) of the U.S Food, Drugs and Cosmetics Act during the NCE Exclusivity Period which is a First U.S. Application for that Licensed Product.
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Examples of Relevant ANDA in a sentence

  • After some discussion, the Sub-Committee agreed that it was premature to forward the draft to the CCC Sub-Committee, and consequently invited the co-sponsors of the proposal and other interested Member Governments and international organizations to submit a revised draft for consideration by the Sub-Committee at its next session.

  • The share of natural gas power plants in installed capacity was about 31.56% in 2007.

  • Also, the poor living conditions in the home – an issue also addressed in several reports, including that of the Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (CPT) – was deemed to breach Articles 3 and 13 of the CRPD in conjunction with the Article 3 of the ECHR.

Related to Relevant ANDA

  • Relevant Area means the counties, parishes, districts, municipalities, cities, metropolitan regions, localities and similar geographic and political subdivisions, within and outside of the United States of America, in which the Employer, the Company or any of its Subsidiaries has carried on Business in which the Participant has been involved or concerned or working on at any time during the period of twelve (12) months prior to the date on which the Participant ceases to be an employed by Employer

  • Relevant Agreement means an agreement benefiting persons who receive educational instruction at the School.

  • Relevant Assets means all of the following:

  • relevant asset means any part of the Network operated from time to time

  • Relevant Amount means the amount of contributions which would have been required to be made by the relevant employer had such contributions been obligatory under the Central Provident Fund Act in respect of —

  • Relevant Accounts means, in respect of any Interest Payment Date, the most recently published audited unconsolidated annual financial statements of UBS Group AG prepared in accordance with the Swiss Code.

  • Relevant Anniversary See "Bankruptcy Loss Amount."

  • relevant authority means the authority of which M is a member;

  • relevant week means the reduction week or part-week in which the capital in question of which the applicant has deprived himself within the meaning of paragraph 67(1)—

  • Relevant Amounts means the Outstanding Principal Amounts of the Notes, together with any accrued but unpaid interest and additional amounts (as described in Condition 10 (Taxation)) due on the Notes. References to such amounts will include amounts that have become due and payable, but which have not been paid, prior to the exercise of any Danish Statutory Loss Absorption Powers by the Relevant Resolution Authority;

  • Relevant Authorities means any governmental or statutory authority with the

  • Relevant Account Holder means any account holder with the Relevant Clearing System which has Underlying Notes (as defined in the definition of “Global Bearer Note”) credited to its securities account from time to time;

  • Relevant Announcement Date means the date that is the earlier of (a) the date of the first public announcement of the relevant Change of Control and (b) the date of the earliest Relevant Potential Change of Control Announcement (if any);

  • Relevant Party means each Loan Party and Sponsor (and, collectively “Relevant Parties”).

  • relevant proceedings means proceedings for contempt of court or proceedings under Schedule 2 to the Anti-social Behaviour, Crime and Policing Act 2014;

  • Relevant Page means the relevant page on Bloomberg or such other information service provider that displays the relevant information.

  • Relevant Law means all legislation, codes of practice, standards, guidelines and regulations (in each case having the force of law) together with all applicable regulations and rules (including the Event Rules) applicable to the subject matter (whether obligations, goods or services) in question;

  • relevant premises means any office premises occupied by the Appointee in relation to the Appointed Business and to which members of the public have access;

  • Relevant Ship means the Ships and any other vessel from time to time (whether before or after the date of this Agreement) owned, managed or crewed by, or chartered to, any Relevant Party;

  • Relevant Parties means the Agent, each Borrower, each Security Party, the Security Trustee, each Lender and the Swap Bank;

  • Security Party means each Owner, the Approved Manager and any other person (except a Creditor Party) who, as a surety or mortgagor, as a party to any subordination or priorities arrangement, or in any similar capacity, executes a document falling within the final paragraph of the definition of “Finance Documents”;

  • Relevant Personnel means the Data Processor’s employees, agents and personnel and such other personnel of the Data Controller as may be approved in writing by the Data Controller from time to time in respect of access to the Personal Data;

  • authorised party means the party referred to in Article XIII(3);

  • relevant Minister means the Secretary of State or the Minister for the Cabinet Office;

  • existing vessel means a vessel which is not a new vessel;

  • Relevant Land in relation to Eligible Existing Tenure or Special Advance Tenure, means the land which is the subject of that Eligible Existing Tenure or Special Advance Tenure, as the case may be; “second variation date” means the date on which clause 3 of the variation agreement made on or about 7 November 2011 between the State and the Company comes into operation;