Generic drug product definition

Generic drug product means a drug product that is approved

Generic drug product means a drug identified by its chemical or non-proprietary name considered to be bioequivalent to the Brand Drug Product that has been determined to be a Covered “generic” Medication by SOUTHERN SCRIPTS.

Generic drug product means a drug marketed without a trade name as a substitute for an innovator or previously patented pioneer drug.

Examples of Generic drug product in a sentence

• Know the regulatory approval process and their registration in Indian and international marketsCourse content: Unit I 10Hours New Drug Discovery and developmentStages of drug discovery, Drug development process, pre-clinical studies, non-clinical activities, clinical studies, Innovator and generics, Concept of generics, Generic drug product development.

• The data requirements against the sections of Clinical & non-clinical overview/summary is optional for both New drug product and Generic drug product.

• Kanfer, Generic drug product development solid oral dosage forms, Marcel dekker.MPY- 303 DRA : INTELLECTUAL PROPERTY RIGHTSUnit IIntellectual property: Trade related intellectual property rights: Patent, Industrial Designs, Trade Mark, Copyright, Geographical Indication, Layout Designs of Integrated Circuit, Protection of Undisclosed Information/Trade Secrets.

• Generic drug product development: New York: Informa Health care, USA.

• New York: Marcel Dekker Inc; Introduction to Generic drug product development; 2005; 8.

More Definitions of Generic drug product

Generic drug product means a drug product that is approved and designated by the federal Food and Drug Administration as a therapeutic equivalent for a reference listed drug product, including a drug product listed in the New Jersey Generic Formulary by the Drug Utilization Review Council pursuant to P.L.1977, c.240 (C.24:6E-1 et al.).

Generic drug product means a drug that is either a Multi-Source Generic or a Single-Source Generic or a DAW 5 Claim and not a Specialty Drug.

Generic drug product means a Drug Product with an FDA-approved “Abbreviated New Drug Application” (or “ANDA”), provided such Drug Product (i) is available from more than two (2) Drug Product manufacturers and/or

Generic drug product means prescription drug products and insulins that are approved and designated by the United States Food and Drug Administration as a therapeutic equivalent for reference-listed drug products. The term includes drug products listed in the New Jersey Generic Formulary by the Drug Utilization Review Council pursuant to the "Prescription Drug Price and Quality Stabilization Act," P.L.1977, c.240 (C.24:6E-1 et al.).

Generic drug product means a regulated drug product that qualifies, under applicable laws and/or regulations, for an expedited regulatory approval process in the relevant market because such drug product has substantially the same or similar active ingredient and/or Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. formulation as, and is indicated for substantially the same or similar indication as, another regulated drug product that has already been approved for commercial sale by the United States Food and Drug Administration, or by a similar regulatory authority in the relevant market.

Generic drug product means prescription drug products and

Generic drug product means a Drug Product with an FDA-approved “Abbreviated New Drug Application” (or “ANDA”) and determined using indicators from Medi-Span (or other nationally recognized drug database) on the basis of a standard brand/generic algorithm utilized for all MedTrak clients, which shall be provided to TPA upon request