ANDA definition

ANDA means Abbreviated New Drug Application.
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ANDA means an Abbreviated New Drug Application, or similar application for marketing approval of a Product submitted to the FDA.
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ANDA means an Abbreviated New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA.
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Examples of ANDA in a sentence

  • PENTING: PERJANJIAN INI MENGANDUNGI TERMA ▇▇▇ SYARAT YANG DITERIMA PAKAI UNTUK KAD ▇▇▇ AKAUN KAD ANDA.

  • ANDA TIDAK BOLEH MENGGUNAKAN KAD SEBELUM TARIKH SAH (JIKA ADA) ATAU SELEPAS TARIKH SAH LAKU YANG DICETAK PADA MUKA DEPAN KAD.

  • JIKA ANDA TIDAK MAHU TERIKAT DENGAN PERJANJIAN INI, POTONG DUA KAD ▇▇▇▇ ▇▇▇ KEMBALIKANNYA KEPADA KAMI.

  • MELAINKAN ANDA BERBUAT DEMIKIAN, KAMI MENGANGGAP ANDA TELAH MENERIMA PERJANJIAN INI.

  • Rhythm will be responsible for obtaining, at its expense, all regulatory and governmental approvals and permits necessary for Rhythm’s use of any Product Developed and/or Manufactured under this Agreement, including, without limitation, IND, ANDA, and NDA submissions and any analogous submissions filed with the appropriate Authority of a country other than the United States.


More Definitions of ANDA

ANDA means an abbreviated new drug application filed with the FDA pursuant to 21 U.S.C. § 355(j) and 21 C.F.R. § 314.3.
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ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.
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ANDA means an Abbreviated New Drug Application filed pursuant to the requirements of the FDA, or the equivalent application in any other country or jurisdiction, required before Commercial Sale of a drug product.
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ANDA means (i) (x) an abbreviated new drug application (as defined in the FD&C Act) and (y) any similar application or functional equivalent relating to any new drug application applicable to or required by any non-U.S. Governmental Authority, and (ii) all supplements and amendments that may be filed with respect to any of the foregoing.
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ANDA means abbreviated new drug application.
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ANDA means an abbreviated new drug application filed with the FDA pursuant to section 505(j) of the FDCA, along with all supplements and amendments thereto, and any similar application for marketing authorization of a product commonly referred to as a “generic” product required by any country, jurisdiction or Governmental Authority other than the United States.
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ANDA means an abbreviated new drug application filed pursuant to the requirements of the FDA pursuant to 21 C.F.R. Part 314 to obtain regulatory approval for a product in the United States, or the equivalent application or filing in another country (as applicable).
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