NDA Supplement definition

NDA Supplement means the Supplement to the NDA filed by Syntex on November 14, 1996.
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NDA Supplement means a supplemental filing to a NDA.
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Examples of NDA Supplement in a sentence

  • Unimed shall continue to fulfill this obligation regardless of whether the NDA Supplement is approved for so long as tablets are available; provided, however, that once tablets are available for commercial sale, Unimed may cease distribution under the Compassionate Use Program.

  • CRC submits this Supplement to reinstate the SecreFlo™ trade name and ensure that FDA’s files are updated and consistent on this point (i.e., NDA Supplement approval letter and Orange Book listing).

  • Unimed shall not be obligated to pay to Syntex any of the Additional Payments unless the NDA Supplement is approved by the FDA within two (2) years of the Effective Date.

  • The parties acknowledge that there is an FRS in the Active Ingredient and the parties are endeavoring to solve the problem in accordance with Section 3.7. Until the NDA Supplement is approved by the FDA, and there is no guaranty that it will be approved, the Product may not be sold commercially but only supplied under the investigator-held IND for compassionate use.

  • Unimed's obligation to pay the remaining XXXXX dollars ($XXXXX) is contingent upon the NDA Supplement being approved by the FDA ("Additional Payments").

  • Control Unit shall assure that all test samples are taken in accordance with approved SOP’s and as detailed in the approved NDA Supplement.

  • Following Closing, Unimed will be responsible for any regulatory work, including the NDA Supplement.

  • SuperGen shall (i) be solely responsible for applying for and obtaining all approvals from Regulatory Authorities relating to registration of the API; (ii) pay any applicable user fee for such registration of the API; and (iii) own the NDA Supplement.

  • Profile shall provide to CoTherix, at no charge to CoTherix, reasonable assistance with CoTherix’s NDA and NDA Supplement, including without limitation providing such documentation, including test reports and data, with respect to the AAD Devices as is reasonably requested by CoTherix.

  • Following FDA approval of the NDA, CoTherix intends to file with the FDA an NDA Supplement seeking approval of the delivery of Ventavis through the I-Neb (“NDA Supplement”).

Related to NDA Supplement

  • Country Supplement means a supplement to this Prospectus specifying certain information pertaining to the offer of Shares of the Company or a Fund or Class in a particular jurisdiction or jurisdictions.

  • Dietary supplement means a product, other than tobacco, that:

  • Asset Pool 1 Supplement means the Asset Pool 1 Supplement dated as of October 9, 2002, by and between the Issuer and the Indenture Trustee, as amended and supplemented from time to time.

  • Joinder Supplement means an agreement among the Borrower, a Lender, its Lender Agent and the Administrative Agent in the form of Exhibit E to this Agreement (appropriately completed) delivered in connection with a Person becoming a Lender hereunder after the Closing Date.

  • mobility supplement means a supplement to which paragraph 9 of Schedule 4 refers;