Established name definition

Established name means the same as defined in 21 C.F.R. 8 299.4.
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Examples of Established name in a sentence

  • No.Proposed name:Truxima Established name: CT-P10* Strength(s): 100 mg/10 mL, 500 mg/50 mL Usual Dose:NHL: the dose is 375 mg/m2.

  • Established name needs to be expressed as “Argatroban Injection”, which only first letter of each word is capitalized.

  • Established name and propri- etary name, as applicable, of the FDA- approved counterpart drug and NDA or ANDA number.

  • The recipient must submit a progress report to HRSA on an annual basis via the Electronic Handbooks (EHBs).

  • Established name = [Drug] [Route of Administration] [Dosage Form] ItemItems in Proposed Labeling Assessment of Carton and Container Labeling: Adequate Any deficiencies should be listed at the end in the “ITEMS FOR ADDITIONAL ASSESSMENT.” ITEMS FOR ADDITIONAL ASSESSMENT Overall Assessment and Recommendation:The labeling information is in general adequate from CMC perspective.

  • Established name needs to be expressed as “Argatroban Injection”, which only first letter of each word is capitalized.2. Administration route should be: for intravenous use(b) (4)3.

  • Prohibited Acts, Penalties, Enforcement• Commercial Container Label– Name & address of mfg, packer, distributor– Established name of product– Ingredient information (quantity & proportion of each api)– Names of inactive ingredients– Statement of identity– Quantity in terms of weight or measure– Net qty of container– Recommended or usual dosage or reference to PI– “Rx only” symbol, or federal legend:• “caution: Federal Law Prohibits dispensing without prescription”III.

  • Data provided by Thomson & Thomson’s SAEGIS ™ Online Service, available at www.thomson-thomson.comTable 1: Potential Sound-Alike/Look-Alike Names Identified by Expert Panel Product NameDosage form(s), Established name, Available StrengthsUsual adult dose*Other**Tygacil™Tigecycline, 50 mg Vial for InjectionInitial intravenous loading dose of 100 mg, followed by 50 mg every 12 hours for 5 to 14 days.

  • The “1%” was removed from the principal display.2. The sequence of Established name, active ingredient and dosage form was revised to ne expressed as the total drug content followed by the concentration in a smaller sized font.3. The statement “For I.V. Administration” was change to “For Intravenous Administration”.4.

  • Established name in the labels should be at least 50% of the tradename.3. Facility Inspection is still pending.”In an addendum to the August, 2012, ONDQA review, finalized on January 7, 2013, the ONDQA reviewer reported that outstanding issues related to the CDRH consult review and labeling had been addressed.

Related to Established name

  • Established catalog price means the price included in a catalog, price list, schedule, or other form that:

  • Established Grade means that grade established by the City for the particular area in which a sidewalk is to be constructed.

  • Established Rate means the rate for the conversion of the Specified Currency (including compliance with rules relating to roundings in accordance with applicable European Community regulations) into euro established by the Council of the European Union pursuant to Article 123 of the Treaty;

  • Established catalogue price means the price included in a catalogue, price list, schedule, or other form that:

  • Established geographic service area means a geographic area, as approved by the Commissioner and based on the carrier's certificate of authority to transact insurance in this state, within which the carrier is authorized to provide coverage;

  • Board-Established Criteria means criteria that the Board of a Regulated Fund may establish from time to time to describe the characteristics of Potential Co-Investment Transactions regarding which the Adviser to the Regulated Fund should be notified under Condition 1. The Board-Established Criteria will be consistent with the Regulated Fund’s Objectives and Strategies (defined below). If no Board-Established Criteria are in effect, then the Regulated Fund’s Adviser will be notified of all Potential Co-Investment Transactions that fall within the Regulated Fund’s then-current Objectives and Strategies. Board-Established Criteria will be objective and testable, meaning that they will be based on observable information, such as industry/sector of the issuer, minimum EBITDA of the issuer, asset class of the investment opportunity or required commitment size, and not on characteristics that involve a discretionary assessment. The Adviser to the Regulated Fund may from time to time recommend criteria for the Board’s consideration, but Board-Established Criteria will only become effective if approved by a majority of the Independent Directors (defined below). The Independent Directors of a Regulated Fund may at any time rescind, suspend or qualify their approval of any Board-Established Criteria, though Applicants anticipate that, under normal circumstances, the Board would not modify these criteria more often than quarterly.

  • Established place of business means the place actually occupied either continuously or at regular periods by a dealer or manufacturer where the books and records are kept and the dealer’s or manufacturer’s business is primarily transacted.

  • Printed Name Signature: Date:

  • Registered Name refers to a domain name within the domain of the Registry TLD, whether consisting of two or more (e.g., xxxx.xxxxx.xxxx) levels, about which VNDS or an affiliate engaged in providing registry services maintains data in a registry database, arranges for such maintenance, or derives revenue from such maintenance. A name in a registry database may be a Registered Name even though it does not appear in a TLD zone file (e.g., a registered but inactive name).

  • Established means, for algae and cyanobacteria, plants, terrestrial invertebrates and plant disease−causing micro- organisms, aquatic invertebrates except crayfish, and terrestrial and aquatic vertebrates except fish, present in an area as a self− sustaining population that is dispersed to the extent that eradica- tion is either infeasible or will take a significant effort over a period of several years.

  • Established business relationship means a relationship between a seller and a consumer based on:

  • Locational UCAP means unforced capacity that a Member with available uncommitted capacity sells in a bilateral transaction to a Member that previously committed capacity through an RPM Auction but now requires replacement capacity to fulfill its RPM Auction commitment. The Locational UCAP Seller retains responsibility for performance of the resource providing such replacement capacity.

  • Retail establishment means any business facility that sells goods directly to the consumer whether for or not for profit, including, but not limited to, retail stores, restaurants, pharmacies, convenience and grocery stores, liquor stores, seasonal and temporary businesses.

  • Establish means to determine the position of a corner either physically or mathematically.

  • Generic name means a short title which is descriptive of the premium and benefit patterns of a policy or a rider.

  • Sealed Source and Device Registry means the national registry that contains all the registration certificates, generated by both NRC and the Agreement States, that summarize the radiation safety information for the sealed sources and devices and describe the licensing and use conditions approved for the product.

  • Automatic Location Identification Gateway or "ALI Gateway" is a computer facility into which CLEC delivers Automatic Location Identification (ALI) data for CLEC Customers. Access to the ALI Gateway will be via a dial-up modem using a common protocol. "Automatic Number Identification" or "ANI" is the Billing telephone number associated with the access line from which a call originates. ANI and Calling Party Number (CPN) usually are the same number. "Automatic Route Selection" or "ARS" is a service feature that provides for automatic selection of the least expensive or most appropriate transmission facility for each call based on criteria programmed into a circuit Switch routing table or system.

  • Common Language Location Identifier (CLLI means the codes that provide a unique eleven (11) character representation of a network interconnection point. The first eight (8) characters identify the city, state and building location, while the last three (3) characters identify the network component.

  • Associated Natural Gas or “ANG” means Natural Gas produced in association with Crude Oil either as free gas or in solution, if such Crude Oil can by itself be commercially produced.

  • Brand name or “trade name” means a brand name or a trade name, whether registered or not, that is to say, a name or a mark, such as symbol, monogram, logo, label, signature, or invented word or writing which is used in relation to such specified services for the purpose of indicating, or so as to indicate a connection in the course of trade between such specified services and some person using such name or mark with or without any indication of the identity of that person;

  • Product brand name means the name of the product exactly as it appears on the principal display panel of the product.

  • Identification Date means each December 31.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Identification card means an identification card issued under Title 53,

  • Retail food establishment means an operation that sells or offers to sell food directly to a consumer. Retail food establishment includes both a retail grocery and a food service establishment but does not include a food processing plant.

  • authorized control level RBC means the number determined under the risk-based capital formula in accordance with the RBC instructions;