New Drug Applications abbreviated

Abbreviated New Drug Application antithyroglobulin antibody antithyroid peroxidase antibody area under the (time-concentration) curve beta-human chorionic gonadotropin central nervous system... 

When a generic manufacturer completes an Abbreviated New Drug Application (ANDA), the bioequivalency test data are highly likely to be the section... 

Proposal to Withdraw Approval of Two New Drug Applications and One Abbreviated New Drug Application Terfenadine, Hoechst Marion Rousssel, Inc and Baker Norton Pharmaceuticals, Fed Regist., Docket No. 96N-0512, 1997, 1998. Part 216 Pharmacy Compounding, Drug Products Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness, Cite 216.24. 

Abbreviated New Animal Drug Applications (ANADAs), 21 579 Abbreviated New Drug Application (ANDA) process, 21 575 Abbreviations, l xvii—xxiv 2-26 xv-xxii ABCD fiber categorizing system, 9 199 Abciximab, 4 104t 5 173... 

Content and format of an abbreviated application Refusal to approve an abbreviated new drug application... 

For new drug products with little or no effective patent life, generic firms are prohibited from filing an abbreviated new drug application within the first 5 years of the product life. Most European countries prohibit such filing within the first 10 years of market life. 

Form 356h is a harmonized form, and a Sponsor can use it for NDA, BLA, and Abbreviated New Drug Application (ANDA, see Section 8.2.5). Page 1 of the form requires Applicant Information, Product Description, Application Information, and Establishment Information. Page 2 requires the provision of a number of items to substantiate the application. The items to be submitted under Form 356h are as follows ... 

The Hatch-Waxman Act dramatically altered the nature and terms of generic competition after 1984. First, the Act established an Abbreviated New Drug Application (ANDA), which substantially reduced the cost of generic entry. Second, the Act allowed generic manufacturers to conduct their testing prior to patent expiration. This allowed generics to enter the market much more quickly after patent expiration than previously. 

Abbreviated New Drug Application Active pharmaceutical ingredient Active pharmaceutical ingredients for generics Brazil, Russia, India, and China Confidentiality disclosure agreement Compound annual growth rate... 

The evidence of formal written procedures is one of the requirements of cGMP as well as the SOP stated in the Abbreviated New Drug Application (ANDA) and (NDA) New Drug Application to ensure compliance to cGMP requirements. 

The references used in the development of abbreviated new drug application (ANDA) file should be cited at the end of the sterility assurance report. 

Drug Price Competition and Patent Restoration Act of 1984 Abbreviated new drug applications for generic drugs. Required bioequivalence data. Patent life extended by amount of time drug delayed by FDA review process. Cannot exceed 5 extra years or extend to more than 14 years post-NDA approval. 

A comparability protocol may be submitted with a new drug application (NDA), abbreviated new drug application (ANDA), or supplements to these applications. 

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