ANDA Filing definition

ANDA Filing means with respect to Generic Tussionex, the abbreviated new drug application requesting permission to place a drug on the market in accordance with section 505(j) of the FDCA (21 U.S.C. 355(j)) and 21 C.F.R. 314, Part 314 Subpart C, and all supplements filed pursuant to the requirements of the FDA, including all documents, data and other information concerning the applicable drug which are necessary for FDA approval to market the drug in the United States.
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ANDA Filing means that a Third Party files an ANDA with the FDA with regard to a Product in the [†] period after the expiration of the last to expire of U.S. Patents Nos. [†] and [†] (including any patent term extension thereof).
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ANDA Filing means that a Third Party files an ANDA with the FDA with regard to a Product in the [†] period after the expiration of the last to expire of U.S. Patents Nos. [†] and [†] (including any patent term extension thereof). [†] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
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Examples of ANDA Filing in a sentence

  • Inc., Civil Action No. 05-CV-1089 (JCL), pending in the United States District Court for the District of New Jersey; and (c) any action filed under Title 35, United States Code, 35 U.S.C. §§ 271 and 281 against any Modafinil Paragraph IV ANDA Filing Entity.

  • CPI shall source all bulk materials, active ingredients, excipients and other manufacturing and test materials needed in order to manufacture and release Products in accordance with this Agreement and the ANDA Filing.

  • The Parties acknowledge that Neos owns the ANDA Filing, including, without limitation, the CMC Section thereof.

  • As such, only the Regulatory Consultant shall have access to the unredacted ANDA Filing and batch records containing CPI’s RC Confidential Information.

  • PFIZER shall have the only right, but no obligation, to initiate patent infringement litigation based on any ANDA Filing concerning any Athersys Exclusive Patent Rights in connection with the Field, at its own expense.

  • The Parties have further agreed, pursuant to Section 9.2 of the Agreement, that CPI will file a DMF for DRC and NEOS will file a Supplemental Application with respect to the ANDA Filing.

  • Subject to the special circumstances of Section 7.6 (ANDA Filing), if Company does not take steps to ▇▇▇▇▇ such infringement or does not intend to prosecute or defend an Action within [*] after receiving notice or otherwise becoming aware of such infringement or claim, Company shall promptly inform MRKDG and MRKDG then shall have the right, but not the obligation, to attempt to resolve such infringement or claim, including by filing an Action and to compromise or settle any such infringement or claim.

  • For purposes of clarity, nothing in this Agreement or in the Provigil Settlement Agreement shall obligate Cephalon to seek injunctive or other relief to stop any Other Modafinil Paragraph IV ANDA Filing Entity from offering to sell or selling Subject Modafinil Products in the United States.

  • Each Party agrees that its activities under this QAA will be conducted in accordance with applicable Laws and such Party’s SOPs. The Parties acknowledge and agree that certain of CPI’s confidential and proprietary information regarding the manufacture of DRC is contained within the CMC Section of the ANDA Filing (“CPI RC Confidential Information”) to which NEOS shall not have access.

  • Product B Sano FDA Drug Name ANDA# Filing Date Accepted Date Nicotine Transdermal System 74-645 03/09/95 04/06/95 7 mg/day* Nicotine Transdermal System 74-611 01/20/95 04/06/95 14 mg/day* Nicotine Transdermal System 74-612 01/20/95 04/06/95 21 mg/day* *Generically equivalent to such strengths in Habitrol(R).


More Definitions of ANDA Filing

ANDA Filing has the meaning set forth in Section 7.6.
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