NDA
NDA. Means the New Drug Application and similar regulatory approvals filed with the FDA or other agencies for the applicable Product, and any amendments or Supplemental New Drug Applications thereto, or documents incorporated by reference.
NDA. Shall mean a new drug application or product license application or its equivalent filed after completion of human clinical trials to obtain marketing approval for a Licensed Product in any country.
NDA. A New Drug Application filed pursuant to the requirements of the FDA, a Biologics License Application filed pursuant to the requirements of the FDA, and any equivalent application filed in any country outside of the Territory, together, in each case, with all additions, deletions, or supplements thereto.
Found in
MARINUS PHARMACEUTICALS INC contract
NDA. Shall mean New Drug Application to be filed with the FDA by CLARUS for the Marketing Authorization for the Finished Product.
Found in
CLARUS THERAPEUTICS INC contract
NDA. The Mutual Non-Disclosure Agreement, dated August __, 2013, entered into by and among Cytori, and Lorem.
Found in
CYTORI THERAPEUTICS, INC. contract
NDA. The Confidentially and Non-Disclosure Agreement between Seller and ASK dated January 25, 2018.
NDA. Is defined in paragraph 10.c
Found in
FedEx contract
NDA. A New Drug Application or Biologic License Application filed with the U.S. Food and Drug Administration for marketing approval of a pharmaceutical product or any successor applications or procedures, and all supplements and amendments that may be filed with respect to the foregoing. The term "NDA" shall not include applications for pricing or reimbursement approval.
Found in
WINDTREE THERAPEUTICS INC contract
NDA. (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, as more fully defined in 21 C.F.R. ยง 314.50 et seq., or (ii) any non-United States counterpart of such a New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any non-United States counterparts) that may be filed with respect to the foregoing
Found in
ProPhase Labs, Inc. contract
NDA. Means each of the Company NDA and the IFID NDA
All Definitions
Found in
PEABODY ENERGY CORP contract