Reference Listed Drug definition

Reference Listed Drug means a listed drug identified by the FDA as a drug product upon which an applicant may rely in seeking approval of an ANDA (or any equivalent process as may be available at the time).
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Reference Listed Drug means [ * ].
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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.
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Examples of Reference Listed Drug in a sentence

  • The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date.

  • Single-Dose Pharmacokinetics and Tissue Distribution of Intravenous and Subcutaneous Administered Reference Listed Drug (RLD) and Alternate Formulation.

  • The individual product record contains the Therapeutic Equivalence Code, Reference Listed Drug symbol, Reference Standard symbol, applicant holder, strength(s), New Drug Application number, product number, and approval date.

  • By clicking on the “Confirm Order” (or similar) button, that is presented to you at the time of your “Order” or approving or sending your Order to us in any other way or means, or by using or accessing Products, (i) you indicate your assent to be bound by this GTC terms and (ii) you state that you purchase or use the Products for your business purposes and you accept that you do not qualify as a “consumer” under any choice of law.

  • Considering the pivotal studies of the Reference Listed Drug, it is assumed that the active test and RLD will have approximate success rates at 21% and the vehicle cream will have an approximate success rate of 9%.

  • FR notices no longer applicable are removed from the Annual Edition (i.e., there is a currently marketed Reference Listed Drug and no applicable patent or exclusivity).

  • This study is designed to provide the clinical “bridge” to the FDA’s finding of safety and efficacy for the Reference Listed Drug (s.c. Apomorphine).

  • For these products, overages can be included only for justified reproducible manufacturing losses and/or for an ANDA product to match the overage present in the Reference Listed Drug.

  • The minutes of the Governing Board or committee meetings shall contain:a.

  • An abbreviated new drug application that refers to a Reference Listed Drug (RLD) approved pursuant to a suitability petition must demonstrate that the proposed product is bioequivalent to the RLD, and it must include appropriate patent certification(s) and an exclusivity statement with respect to the listed drug which served as the basis for the approved suitability petition.


More Definitions of Reference Listed Drug

Reference Listed Drug shall have the meaning set forth in Section 1.39.
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Reference Listed Drug shall have the meaning set forth at 21 C.F.R § 314.3.
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Reference Listed Drug means the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA. See 21 CFR 314.3(b). FDA publishes the identification of RLDs in the Approved Drug Products with Therapeutic Equivalence Evaluations (i.e., Orange Book), available at https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence- evaluations-orange-book.
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Reference Listed Drug means Surmontil®.
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Reference Listed Drug means the NDA product, as defined above.
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Related to Reference Listed Drug

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • Covered drug means any prescription drug that:

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Generic Drug means a Prescription Drug that is medically equivalent to a Brand Name Drug as determined by the FDA. It meets the same standards as a Brand Name Drug for purity, safety, strength and effectiveness and is manufactured and sold under its chemical, common, or official name.

  • Invalid Drug Test means the result of a drug test for an oral fluid specimen that contains an unidentified adulterant, or an unidentified substance, that has abnormal physical characteristics, or that has an endogenous substance at an abnormal concentration preventing the laboratory from completing or obtaining a valid drug test result.

  • Legend drugs means any drugs which are required by state

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Reference Exchange Rate means the exchange rate which is used as the basis to calculate any currency exchange and which is made available by the payment service provider or comes from a publicly available source;

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Listing Market means the national securities exchange on which any securities of the Company are listed for trading, and if not listed for trading, by the rules of the Nasdaq Stock Market.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Reference Gilt means the Treasury Stock specified as such in the relevant Final Terms for so long as such stock is in issue, and thereafter such issue of index-linked Treasury Stock determined to be appropriate by a gilt-edged market maker or other adviser selected by the Issuer and approved by the Bond Trustee (an “Indexation Adviser”).

  • Canadian-U.S. Exchange Rate means, on any date, the inverse of the U.S. - Canadian Exchange Rate in effect on such date;

  • Approved Market means the Over-the-Counter Bulletin Board, the Nasdaq Stock Market, the New York Stock Exchange or the American Stock Exchange.

  • Foreign market vehicle means any motor vehicle originally manufactured outside the United States,

  • Nasdaq National Market means the National Association of Securities Dealers Automated Quotation National Market or any successor national securities exchange or automated over-the-counter trading market in the United States.

  • exempt market dealer means a person or company registered in the category of exempt market dealer;

  • Multi-Exchange Index , if applicable, means each Reference Item specified under the heading "Underlying" in the Product Terms to be a Multi-Exchange Index.

  • Automated driving system means the same as that term is defined in Section 41-26-102.1.

  • Reference Index means each of the indices comprising the Reference Portfolio.

  • Food and food ingredients means substances, whether in liquid, concentrated, solid, frozen, dried, or dehydrated form, that are sold for ingestion or chewing by humans and are consumed for their taste or nutritional value. Food and food ingredients do not include alcoholic beverages and tobacco.

  • Applicable Exchange Rate means, with respect to any Contract denominated and payable in Euros or GBPs on any day, the lesser of (a) the applicable currency Dollar spot rate used by the Borrower (as determined by the Collateral Manager) to acquire such currency on the date such Contract is included in the Borrower Collateral and (b) the Applicable Conversion Rate for such currency.

  • Reference Market Price shall initially mean $25.165 and, in the event of any adjustment to the Conversion Price pursuant to Sections 15.5(a), (b), (c), (d), (e), (f) or (g), the Reference Market Price shall also be adjusted so that the ratio of the Reference Market Price to the Conversion Price after giving effect to any such adjustment shall always be the same as the ratio of $25.165 to the initial Conversion Price specified in the form of Debenture attached hereto (without regard to any adjustment thereto).

  • Flea market means a market place, other than a dealer's location licensed under this chapter, where a space or location is provided for a fee or compensation to a seller to exhibit and offer for sale or trade, motor vehicles to the general public.