FDA Approval Date definition

FDA Approval Date means the date on which the United States Food and Drug Administration grants Regulatory Approval of C2B8 for manufacture and sale in the United States.

FDA Approval Date means the date of receipt of FDA approval allowing for Patheon’s manufacturing, testing, and packaging for the Product from the Phase I Filling Space and Phase II Manufacturing Space.

FDA Approval Date means the date of receipt by Client of Regulatory Approval in the United States for Products Manufactured at the Manufacturing Suite.

Examples of FDA Approval Date in a sentence

• Baseline data is the product information that includes FDA Approval Date, Market Date, DESI code, etc.

• EC SHALL REPLACE OR REPAIR ANY DAMAGED OR DEFECTIVE DEVICES OR WORK FREE OF CHARGE DURING THIS PERIOD.

• Valid values: AHF = Injectable Anti-Hemophilic Factor CAP = CapsuleEA = EACHGM = Gram ML = MilliliterSUP = Suppository TAB = TabletTDP = Transdermal Patch FDA Approval Date: NDA (including Authorized Generic), ANDA, or BLA approval date.

• Contractor Service Agreement: The overall system must have a Contract Service Agreement to include firmware updates that covers at least three years of use past installation date.

• Valid values:AHF = Injectable Anti-Hemophilic Factor CAP = CapsuleSUP = Suppository GM = GramML = Milliliter TAB = TabletTDP = Transdermal Patch EA = Each FDA Approval Date: NDA or monograph approval date.

More Definitions of FDA Approval Date

FDA Approval Date means the date upon which any party receives FDA Approval.

FDA Approval Date means the date of receipt of Marketing Authorization from the FDA for the use of the Shingles Product; provided such approval does not occur later than June 30, 2018.

FDA Approval Date means the date on which the FDA grants all approvals necessary for Kedrion to market and sell Private Label Albumin Product and Private Label IVIG Product. In the event the FDA approves the marketing and sale by Kedrion of one of the two products before the other, the FDA Approval Date shall be the latter of those two approval dates.

FDA Approval Date means the date of approval by the FDA of a NDA and satisfaction of any related FDA requirements (if any) for the Products.

FDA Approval Date means the date on which the United States Food and Drug

FDA Approval Date has the meaning set forth in Section 2.03(a).

FDA Approval Date means the date on which the U.S. Food and Drug Administration approves the use of KRN 5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics.