Approved Labeling means, with respect to a Product in a country: (a) the Regulatory Authority-approved full prescribing information for such Product in such country; and (b) the Regulatory Authority-approved labels and other written, printed or graphic materials on any container, wrapper or any package insert that is used with or for such Product in such country.
Approved Labeling means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.
Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling which contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.
Examples of Approved Labeling in a sentence
Unit Skylights shall be labeled by a LA City Approved Labeling Agency.
Indeed, far from the consistent application of Teva that Nova posits, the Federal Circuit routinely declines to defer to factual findings.
Plan B Approved Labeling, available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s011_Plan_B_P RNTLBL.pdf (last visited Apr.
Unit Skylights shall be labeled by an LA City Approved Labeling Agency.
These changes update and are more representative of the noxious weeds actually found in Utah.
More Definitions of Approved Labeling
Approved Labeling means the approved labeling for Product or Infusion set as set forth in the applicable Regulatory Approval in a particular jurisdiction.
Approved Labeling means, with respect to a Collaboration Product: (a) the Regulatory Authority-approved full prescribing information for such Collaboration Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Collaboration Product.
Approved Labeling means, with respect to a Cost Profit Sharing Product: (a) the Regulatory Authority-approved full prescribing information for such Cost Profit Sharing Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Cost Profit Sharing Product.
Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling in accordance with sections 201.56 and 201.57 of title 21, Code of Federal Regulations that contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.
Approved Labeling shall include all of the following : (i) the Product label to be affixed to the bottle; (ii) the Product package insert (the "Insert"); and (iii) the Product patient-information leaflet, in the form attached as Exhibit E.
Approved Labeling means, with respect to each Product in a country in the Territory: (a) the Regulatory Authority-approved full prescribing information for such Product in such country; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Product in such country.
Approved Labeling means, with respect to a Collaboration Product: (a) the Regulatory Authority-approved full prescribing information for such Collaboration Product; and (b) the Regulatory Authority-approved labels (or other label provided by Taiho that is in compliance with applicable Laws) and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Collaboration Product.