Taro ANDA definition

Taro ANDA means ANDA No. 208098 for diclofenac sodium topical solution, 2% as it exists as of the Effective Date, including any future supplements, amendments and/or modifications to the ANDA that were made to gain approval from the FDA, provided such supplements, amendments and/or modifications do not change the active ingredient, dosage form, reference listed drug, indication or AB rating of any generic product described in the ANDA as it exists as of the Effective Date.
Sample 1

Examples of Taro ANDA in a sentence

  • Each Party acknowledges and agrees that the 30 month stay imposed by FDA in relation to the approval of the Taro ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) should be terminated.

  • From and after the Effective Date, Plaintiffs shall not (a) file any citizen petition or other regulatory submissions with the FDA or any other governmental agency, or otherwise interfere with Taro’s efforts to: (i) obtain FDA approval of the Taro ANDA; or (ii) Market the Taro Generic Product as of the date and under the terms provided in this Settlement Agreement; or (b) Officially Discontinue the NDA Product prior to expiration of the Licensed Patents for reasons other than safety or efficacy.

  • No provision of this Settlement Agreement shall be affected by any delay in the approval of the Taro ANDA by the FDA, or the failure of Taro to obtain FDA approval of the Taro ANDA.

  • For the avoidance of doubt, the foregoing shall not preclude Taro from filing and/or maintaining in the Taro ANDA any certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) to any patents listed in the Orange Book in connection with the PENNSAID® 2% NDA.

  • If a Governmental Entity directs or recommends to Taro that Taro transfer the Taro ANDA to a Third Party, Taro may disclose a copy of this Settlement Agreement to a Third Party in connection with such a possible transfer so long as the Third Party agrees to confidential treatment of this Settlement Agreement.

Related to Taro ANDA

  • EUMA means the “SAP Delivered Support Agreement” which sets out the terms and conditions under which SAP provides support to End Users and which will be provided by SAP on a deal by deal basis.

  • SADC means the Southern African Development Community;

  • IRDA means the Insurance Regulatory and Development Authority.

  • Production company means a person or entity engaged in the business of making motion picture, television, or radio images for theatrical, commercial, advertising, or education purposes; Reserved

  • BRL means Brazilian real, the lawful currency of Brazil;

  • mg means milligram.

  • India means the territory of India and includes the territorial sea and airspace above it, as well as any other maritime zone in which India has sovereign rights, other rights and jurisdiction, according to the Indian law and in accordance with international law, including the U.N. Convention on the Law of the Sea;

  • POPIA means the Protection of Personal Information Act, No 4 of 2013;

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  • Vintage means the calendar year, Reporting Year, or other calendar period specified by the Parties or the Certification Authority, as applicable, in which the Product is created or first valid for use under an Applicable Program.

  • Crown means the government of the United Kingdom (including the Northern Ireland Assembly and Executive Committee, the Scottish Executive and the National Assembly for Wales), including, but not limited to, government ministers and government departments and particular bodies, persons, commissions or agencies from time to time carrying out functions on its behalf;

  • HKEx means Hong Kong Exchanges and Clearing Limited;

  • GIT means General Instructions to Tenderers

  • MGD means million gallons per day. "mg/l" means milligrams per liter. "ug/l" means micrograms per liter. "ng/l" means nanograms per liter. "S.U." means standard pH unit. "kg/day" means kilograms per day.

  • Chile means the Republic of Chile.

  • EUWA means the European Union (Withdrawal) Act 2018;