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 [ * ].
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Reference Listed Drug shall have the meaning set forth in Section 1.39.
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Examples of Reference Listed Drug in a sentence

  • Key words: ANDA, CDER, FDA, Federal Food, Drug, and Cosmetic Act (FD&C Act), Orange Book, paragraph IV, Reference listed drug (RLD), USFDA.

  • Quality target product profileThe quality target project profile (QTPP) is defined as “A prospective summery of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product‟‟.[17] All product attributes to ensure equivalency of safety and efficacy with respect to RLD (Reference listed drug).

  • Subjects fulfilling inclusion and exclusion criteria will receive study product from the next available sequential randomized kit which contains one of the following three treatment arms: Test drug: Pimecrolimus Cream, 1% Reference listed drug: Elidel® (Pimecrolimus) Cream 1% Placebo: Vehicle of the test drug cream without PimecrolimusEach study product kit will contain three 100 gram tubes of study cream from the same randomized treatment arm.

  • Applicant Response:Fresenius provided reports PD11-NPA-018 and PD11-NPA-018 Amendment 1 which reported data for Reference listed drug lot C511442 (RLD) and APP finished product lot R340-032 (FP) - analyzed by APP’s finished product method.

  • Reference listed drug) for BE studies and the norms for US submissions.

  • A Generic Product must meet the standards established by FDA in RLD (Reference listed drug).

  • Subjects fulfilling inclusion and exclusion criteria will receive study product from the next available sequential randomized kit which contains one of the following three treatment arms:⮚ Test drug: Pimecrolimus Cream, 1%⮚ Reference listed drug: Elidel® (Pimecrolimus) Cream 1%⮚ Placebo: Vehicle of the test drug cream without PimecrolimusEach study product kit will contain three 100 gram tubes of study cream from the same randomized treatment arm.


More Definitions of Reference Listed Drug

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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Reference Listed Drug shall have the meaning set forth at 21 C.F.R § 314.3.
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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 any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • 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 filed with the FDA in accordance with Applicable Law.

  • 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.

  • Locational Marginal Price or “LMP” shall mean the market clearing price for energy at a given location in a Party’s RC Area, and “Locational Marginal Pricing” shall mean the processes related to the determination of the LMP.

  • 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;

  • EEA Regulated Market means a market as defined by Article 4.1(14) of Directive 2004/39/EC of the European Parliament and of the Council on markets on financial instruments;

  • 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 Collateral Obligation denominated and payable in Euros, GBPs, AUDs or CADs on any day, the lesser of (a) the applicable currency-Dollar spot rate used by the Borrower (as determined by the Investment Manager) to acquire such currency on the related Cut-Off Date and (b) the Applicable Conversion Rate for such currency.