Reference Listed Drug definition

Reference Listed Drug means a listed drug identified by FDA or other Regulatory Authority as a drug product upon which an applicant may rely in seeking approval of an ANDA.

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Reference Listed Drug means [ * ].

Reference Listed Drug shall have the meaning set forth in Section 1.39.

Examples of Reference Listed Drug in a sentence

• Without limiting the foregoing, Tishtec shall be responsible for, and shall exert commercially reasonable best efforts in providing to Elite the initial Product formulation composition and process, and conducting, through an acceptable third party, pilot and pivotal Bioequivalence Studies for the Product to evidence bioequivalence to the Reference Listed Drug in accordance with study plan protocols agreed upon by the Parties to this Agreement, and compiling an approvable ANDA for submission to the FDA.

• Nothing in this Agreement gives SHL or its Affiliates the right to file for patent protection or other similar governmental rights (including, but not limited to, Reference Listed Drug filings such as the FDA’s Orange and Purple Books) claiming any invention encompassing, utilizing or disclosing any Customer Materials.

• Neos: Cornerstone: By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ Co President President and CEO Defined [***] (equivalent to [***] mg [***]and [***] mg [***] base [***] Extended Release Oral Suspension Target Specification Color: [***] Flavor: [***] Dosing Regimen: [***] Reference Listed Drug: [***] Container/Closure: [***] oz.

• Without limiting the foregoing, [ * ] shall be responsible for, and shall exert commercially reasonable best efforts in providing to Elite the initial Product formulation composition and process, and conducting, through an acceptable third party, pilot and pivotal Bioequivalence Studies for the Product to evidence bioequivalence to the Reference Listed Drug in accordance with study plan protocols agreed upon by the Parties to this Agreement, and compiling an approvable ANDA for submission to the FDA.

• Nothing in this Agreement gives Customer or its Affiliates the right to file for patent protection or other similar governmental rights (including but not limited to Reference Listed Drug filings such as the FDA’s Orange and Purple Books) claiming any invention encompassing, utilizing, or disclosing any SHL Materials.

More Definitions of Reference Listed Drug

Reference Listed Drug means a previously approved

Reference Listed Drug means a listed Drug Product identified by FDA, or similar Regulatory Authority outside of the United States, as a Drug Product upon which an applicant may rely in seeking approval of any Regulatory Approval Application.

Reference Listed Drug means the listed drug product

Reference Listed Drug shall have the meaning set forth at 21 C.F.R Section 314.3.

Reference Listed Drug means the NDA product, as defined above.

Reference Listed Drug means a previously approved drug identified by the U.S. Food and Drug Administration (FDA) as the drug product to which a proposed generic drug must be compared on an application submitted for approval under specified federal law.

Reference Listed Drug means Surmontil®.