NDA. “NDA” shall mean (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such a New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any foreign counterparts) that may be filed with respect to the foregoing.
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Samples: License Agreement (Discovery Partners International Inc), License Agreement (Infinity Pharmaceuticals, Inc.), License Agreement (Discovery Partners International Inc)
NDA. “NDA” shall mean (a) (i) a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such means a New Drug Application, and (b) all supplements and amendmentsas defined in the FD&C Act, including supplemental New Drug Applications (and any foreign counterparts) that may be is filed with respect the FDA to formally propose that the foregoingFDA approve a new drug for sale and marketing in the U.S., or an equivalent application or submission.
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Samples: Development Agreement (Progenics Pharmaceuticals Inc)
NDA. “NDA” shall mean (a) (i) means a New Drug Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of such a and/or an Abbreviated New Drug Application, and (b) all supplements and amendments, including supplemental New Drug Applications (and any foreign counterparts) that may be filed with respect to the foregoingFDA, together with all amendments and supplements thereto.
Appears in 1 contract
