Section 505(b)(2) NDA definition

Section 505(b)(2) NDA means an NDA filed pursuant to Section 505(b)(2) of the Act.
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Examples of Section 505(b)(2) NDA in a sentence

  • Recent Developments On May 28, 2014, we submitted a Section 505(b)(2) NDA application to the FDA for approval for sale of our Epinephrine PFS product, for the emergency treatment of acute allergic reactions, including anaphylaxis.

  • If the applicant does not challenge one or more listed patents through a Paragraph IV certification, the FDA will not approve the Section 505(b)(2) NDA application until all the listed patents claiming the referenced product have expired.

  • If such a suit is commenced, the FDA is generally prohibited from granting approval of the ANDA or Section 505(b)(2) NDA until the earliest of 30 months from the date the FDA accepted the application for filing, the conclusion of litigation in the generic applicant’s favor or expiration of the patent(s).

  • Dipti Ratnesh Kerkar, daughter of Mr. Tulshidas Naik, 33 years of age, all Indian National and all resident of House No. 434, Voilem bhat, Merces, St. Cruz, Tiswadi-Goa that the Declarants by this deed declare, Confirm and affirm for all legal purposes that the aforesaid are his universal heirs (1) Miss Roshan Chandrakant Kerkar (2) Mr. Deepraj Chandrakant Kerkar, married to Mrs.

  • Under the Hatch-Waxman Act, the FDA can approve an ANDA for a generic version of a branded drug and what is referred to as a Section 505(b)(2) NDA, for a branded variation of an existing branded drug, without requiring such applicant to undertake the full clinical testing necessary to obtain approval to market a new drug.

  • During the five-year exclusivity period, the FDA cannot accept for filing any ANDA seeking approval of a generic version of that drug or any Section 505(b)(2) NDA for the same active moiety and that relies on the FDA’s findings regarding that drug, except that the FDA may accept an application for filing after four years if the follow-on applicant makes a paragraph IV certification.

  • A significant proportion of the cash on hand, resides in the USA segment.Cash - restrictedRestricted cash amounted to $2,033, an increase of $1,109 from $924 in 2019 as cash was applied towards contractual performance obligations.

  • Similar results were found using a parametric t-test for the comparison of the means under both periods.

  • A Section 505(b)(2) NDA is a special type of NDA that enables the applicant to rely, in part, on the FDA’s findings of safety and efficacy of an existing previously approved product, or published literature, in support of its application.

  • If market exclusivity is granted for an NCE, during the exclusivity period, the FDA may not accept for review or approve an abbreviated new drug application, or ANDA, or a Section 505(b)(2) NDA submitted by another company for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.

Related to Section 505(b)(2) NDA

  • Section 504 means section 504 of the Act.

  • Section 502(b)(10) changes means changes that contravene an express permit term or condition. Such changes do not include changes that would violate applicable requirements or contravene federally enforceable permit terms and conditions that are monitoring (including test methods), recordkeeping, reporting, or compliance certification requirements.

  • Section 504 Plan means a student’s individualized plan developed by the student’s Section 504 multidisciplinary team after a pre-placement evaluation finding the student is disabled within the meaning of Section 504 and its implementing regulations.

  • Section 404 Report means management’s report on “internal control over financial reporting” as defined by the SEC and the related attestation report of the independent certified public accountant as described in Section 3(A)(1).

  • Article 55 BRRD means Article 55 of Directive 2014/59/EU establishing a framework for the recovery and resolution of credit institutions and investment firms.

  • Section 385 Expanded Group shall have the meaning set forth in Treasury Regulation Section 1.385-1(c)(4) for an “expanded group”.

  • Section 510(b) Claim means any Claim arising from: (a) rescission of a purchase or sale of a security of the Debtors or an Affiliate of the Debtors; (b) purchase or sale of such a security; or (c) reimbursement or contribution allowed under section 502 of the Bankruptcy Code on account of such a Claim.

  • Section 510(b) Claims means any Claim against any Debtor: (a) arising from the rescission of a purchase or sale of a Security of any Debtor or an affiliate of any Debtor; (b) for damages arising from the purchase or sale of such a Security; or (c) for reimbursement or contribution Allowed under section 502 of the Bankruptcy Code on account of such a Claim; provided that a Section 510(b) Claim shall not include any Claims subject to subordination under section 510(b) of the Bankruptcy Code arising from or related to an Interest.

  • Section 404 means Section 404 of the Sarbanes-Oxley Act of 2002 and the SEC’s rules and regulations promulgated thereunder.

  • Section 102 means section 102 of the Ordinance and any regulations, rules, orders or procedures promulgated thereunder as now in effect or as hereafter amended.

  • Specified Acquisition Agreement Representations means such of the representations and warranties made by, or with respect to, the Company and its Subsidiaries in the Acquisition Agreement as are material to the interests of the Lenders, but only to the extent that the Borrower or its Affiliates has the right to terminate its (or their) obligations under the Acquisition Agreement, or decline to consummate the Acquisition in accordance with the terms of the Acquisition Agreement, as a result of a breach of such representations and warranties.

  • Allocation Agreement or “Agreement” shall mean this NMTC Program Allocation Agreement between the Fund and the Allocatee and Subsidiary Allocatee, as the case may be, including the Organization Specific Terms and Conditions (Schedule 1) and the General Allocation Terms and Conditions (Schedule 2) and any attachments hereto, as such Agreement may, from time to time, be amended in accordance with its terms.

  • subclause means subclause of the Clause in which the term is used;

  • Distribution Agreement has the meaning set forth in the recitals to this Agreement.

  • Required Allocations means (a) any limitation imposed on any allocation of Net Losses or Net Termination Losses under Section 6.1(b) or 6.1(c)(ii) and (b) any allocation of an item of income, gain, loss or deduction pursuant to Section 6.1(d)(i), 6.1(d)(ii), 6.1(d)(iv), 6.1(d)(vii) or 6.1(d)(ix).

  • Section 1110 means Section 1110 of the Bankruptcy Code.

  • Section 338 Forms means all returns, documents, statements, and other forms that are required to be submitted to any federal, state, local or foreign Taxing authority in connection with a Section 338(h)(10) Election, including, without limitation, any "statement of Section 338 Election" and IRS Form 8023 (together with any schedules or attachments thereto) that are required pursuant to Treasury regulations.

  • Distribution Agreements means (i) any and all agreements entered into by a Credit Party, pursuant to which such Credit Party has sold, leased, licensed or assigned distribution rights or other exploitation rights to any Item of Product to an un-Affiliated Person, and (ii) any and all agreements hereafter entered into by a Credit Party pursuant to which such Credit Party sells, leases, licenses or assigns distribution rights or other exploitation rights to an Item of Product to an un-Affiliated Person.

  • Tax Allocation Agreement means the Tax Allocation Agreement between Corporation and New D&B.

  • Tax Matters Agreement means the Tax Matters Agreement to be entered into by and between Parent and SpinCo or any members of their respective Groups in connection with the Separation, the Distribution or the other transactions contemplated by this Agreement, as it may be amended from time to time.

  • Sale and Contribution Agreement means the Sale and Contribution Agreement, dated as of the Closing Date, among the Servicer, the Transferor and the Borrower, as such agreement may be amended, amended and restated, supplemented or otherwise modified from time to time.

  • Acquisition Agreement Representations means such of the representations made by or on behalf of the Target in the Acquisition Agreement as are material to the interests of the Lenders, but only to the extent that the accuracy of any such representation is a condition to the obligations of Holdings or an Affiliate thereof to close under the Acquisition Agreement or Holdings (or an Affiliate thereof) has the right to terminate its obligations under the Acquisition Agreement as a result of a breach of such representations in the Acquisition Agreement.

  • Section 4(2) shall have the meaning set forth in the recitals of this Agreement.

  • sentence means the sanction or combination of sanctions imposed by the sentencing court on an offender who is convicted of or pleads guilty to an offense.

  • Affected Gain has the meaning set forth in subparagraph 4(b) of Exhibit B.

  • Subsection means subsection of the section in which the term is used;