Par ANDA definition

Par ANDA means ANDA No. 202842 filed by Par, as amended from time to time.
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Par ANDA means ANDA No. 205742 for glycerol phenylbutyrate oral liquid, 1.1 gm/mL 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, or AB rating of any generic product described in the ANDA as it exists as of the Effective Date.
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Par ANDA means ANDA No. 205976 (together with any amendments, supplements, or other changes thereto) seeking approval to engage in the ** This portion has been redacted pursuant to a confidential treatment request. Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.
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Examples of Par ANDA in a sentence

  • Includes a Company ANDA final approval for our 15 and 30 mg strengths, and a Par ANDA final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

  • The FDA granted final approval under the Par ANDA for its generic Focalin XR® capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths, and subsequently Par launched the remaining 5 and 40 mg strengths.

  • While we believe that licensing agreements are possible, there can be no assurance that any can be secured.3. Includes a Company ANDA final approval for our 15 and 30 mg strengths, and a Par ANDA final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

  • The FDA recently had granted final approval under the Par ANDA for its generic Focalin XR® capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

  • If and when so developed, the Parties agree that any filings made with the FDA in respect of applications for approval to commercialize such strengths, or any other strengths as may be introduced into the Territory by the owner of the Brand Product, shall be made as amendments to the IPC ANDA or to the Par ANDA, as the case may be, and not as new ANDAs.

  • Within the purview of the Par agreement, Par also applied for and owns an ANDA pertaining to all marketed strengths of generic Focalin XR® (the “Par ANDA”), and is now approved by the FDA, to market generic Focalin XR® capsules in all marketed strengths in the U.S. As with the Company ANDA, calendar quarterly profit-sharing payments are payable by Par to us for its U.S. sales of generic Focalin XR® under the Par ANDA as calculated pursuant to the Par agreement.

  • Includes a Company ANDA (as hereinafter defined under “Material Contracts”) final approval for our 15 and 30 mg strengths, and a Par ANDA (as hereinafter defined under “Material Contracts”) final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

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

  • The FDA recently had granted final approval under the Par ANDA (as defined below) for its generic Focalin XR® capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

  • The Parties hereby agree that Par may elect to develop a 40 mg strength of the Product under the Par ANDA and at its own expense.


More Definitions of Par ANDA

Par ANDA means: (i) ANDA No. 208757 for 12 mg/0.6 mL methylnaltrexone bromide in a single-dose vial product; and (ii) any ANDA filed by Par for 8 mg/0.4 mL and/or 12 mg/0.6 mL methylnaltrexone bromide in a single-dose pre-filled syringe for which Relistor® Injection is the Reference Listed Drug, and, with respect to (i) and (ii), including any amendments, replacements, or supplements that have been made or may in the future be made thereto. For clarity, “supplements” or “replacements” means with respect to an ANDA for 12 mg/0.6 mL methylnaltrexone bromide in a single-dose vial product for which Relistor® Injection is the Reference Listed Drug.
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Related to Par 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.

  • Chile means the Republic of Chile.

  • OPEC means the Organization of Petroleum Exporting Countries.

  • Equality Legislation means any and all legislation, applicable guidance and statutory codes of practice relating to diversity, equality, non-discrimination and human rights as may be in force from time to time in England and Wales or in any other territory in which, or in respect of which, the Supplier provides the Services;

  • ASU means the Accounting Standards Update 2016-02, Leases (Topic 842) by the Financial Accounting Standards Board issued on February 25, 2016.

  • ADN means the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways;

  • Shire means Shire of Augusta Margaret River

  • Universal bilateral modification means a bilateral modification, as defined in FAR subpart 43.1, that updates or incorporates new FAR or AIDAR clauses, other terms and conditions, or special requirements, affecting all USAID awards or a class of awards, as specified in the Agency notification of such modification.

  • EMD means Earnest Money Deposit.

  • SADC means the Southern African Development Community;

  • ATO means the Australian Taxation Office;

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

  • University means Guru Gobind Singh Indraprastha University, Delhi

  • LODR means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015

  • PIR means Problem Identification Report.

  • Oil shale means a group of fine black to dark brown shales containing kerogen material that yields petroleum upon heating and distillation.

  • Raptor means all birds of the orders Falconiformes and Strigiformes, commonly called falcons,

  • RIO means a document published by a service provider specifying terms and conditions on which the other service provider may seek interconnection with such service provider;

  • CJI means criminal justice information collected by criminal justice agencies needed for the performance of their authorized functions, including, without limitation, all information defined as criminal justice information by the U.S. Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Security Policy, as amended and all Criminal Justice Records as defined under §24-72-302, C.R.S.

  • AP legend key means that, in some instances, prior written approval will be required. In this event, the user should adhere to the Uniform Guidance Section 200.407, DOL exceptions Section 2900.16, and contact their project manager or Regional Advisor.

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