Original NDA definition

Original NDA means the original New Drug Application filed with the FDA for the product incorporating API from a source other than Equateq.
Sample 1Sample 2
Original NDA means a complete new NDA that has never before been submitted to the FDA.
Sample 1Sample 2
Original NDA shall have the meaning set forth in Section 3.1(b).
Sample 1Sample 2

Examples of Original NDA in a sentence

  • The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and here to submit patent information—(1) Original NDA.

  • The declara- tions required by this section must be signed by the applicant or patent owner, or the applicant’s or patent owner’s attorney, agent (representa- tive), or other authorized official.(d) When and where to submit patent information—(1) Original NDA.

  • Jessup, Review and Evaluation of Pharmacology Toxicology Data: Original NDA Review (1996) (“the 1996 FDA SBOA”, Ex. 1007A).Public accessibility is based on the “facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Lister, 583 F.3d 1307, 1311 (Fed.

  • Except as amended hereby, the Original NDA remains in full force and effect in accordance with its terms, and each party hereto confirms its obligations thereunder.

  • Abbott shall prepare and provide to CTI for FDA submission the Original IND and Original NDA annual reports, to the extent applicable, and Periodic Report for the period of time during which the Original IND and Original NDA were owned by Abbott.

  • This Original NDA contained safety data from 475 men exposed to at least one dose of intranasal testosterone gel.

  • Environmental fate and effects study reports for Rasilez®/Tekturna® drug substance have been initially reported to the agency in aliskiren film-coated tablets Original NDA 21-985 (submitted 13-Feb-2006).

  • Original NDA application for Ondansetron Oral Soluble Film 8 mg and 4 mg was submitted on 04/07/09 under 505(b)(2) provision using Zofran (Ondansetron) Orally Disintegrating Table 8 mg as reference product.

  • Absence of such genomic information for most of zooplankton species (reviewed in Bucklin et al.

  • Pharmacokinetic Assessments1 1Source: Original NDA 208956 Inclusion criteria:1.


More Definitions of Original NDA

Original NDA means the original New Drug Application filed with the FDA for the product incorporating API from a source other than Equateq. “Party” and “Parties” have the meanings given such terms, respectively, in the preamble of this Agreement.
Sample 1

Related to Original NDA

  • Original RRA shall have the meaning given in the Recitals hereto.

  • Original Note shall have the meaning assigned to such term in the recitals.

  • Original Agreement has the meaning set forth in the recitals.

  • Original Plan means any defined contribution plan which meets the requirements of Code Section 401 and referred to in Article XII of the Plan.

  • Original LLC Agreement has the meaning set forth in the Recitals.

  • Original Notes means the Initial Notes and any Exchange Notes issued in exchange therefor.

  • Existing Agreement has the meaning set forth in the recitals.

  • Original Material means a material provided by one of the Parties and used in the Research Project.

  • Original Facility Agreement means the facility agreement dated 19 December 2018 and made between, amongst others, (i) the Borrower, (ii) the Lenders, (iii) the Mandated Lead Arrangers, (iv) the Facility Agent and the SACE Agent and (v) the Security Trustee.

  • Original Loan Agreement has the meaning set forth in the recitals hereto.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Original Effective Date means the Effective Date under, and as defined in, the Original Credit Agreement.

  • Original package means the unbroken container or wrapping in which any drug or medicine is

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Original Financing Agreement means the development credit agreement for a Social Investment Program Project between the Recipient and the Association, dated April 7, 2003, as amended to the date of this Agreement (Credit No. 3740-BD).

  • Original Project means the Project described in the Original Financing Agreement.

  • Existing Registration Rights Agreement shall have the meaning given in the Recitals hereto.

  • Existing Products Tangible Products and intangible licensed Products that exist prior to the commencement of work under the contract. Existing Products must be identified on the Product prior to commencement of work or else will be presumed to be Custom Products.

  • Amended and Restated Registration Rights Agreement has the meaning set forth in the Recitals.

  • Amending Agreement means the Agreement of which a copy is set out in the Third Schedule to the Iron Ore (Hamersley Range) Agreement Xxx 0000 (which Agreement was approved by the Iron Ore (Hamersley Range) Agreement Act Amendment Act 1968);

  • Initial Agreement has the meaning set forth in the Recitals.

  • Existing Agreements has the meaning as set forth in Section 3.2 hereof.

  • Original Rights shall have the meaning set forth in the definition of "Beneficial Owner" above.

  • Existing Plan means the Amended and Restated Novatel Wireless, Inc. 2000 Stock Incentive Plan.

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation: