Documents

Briefs, oral arguments, agency decisions and the Federal Register.

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  • Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON

    Federal Register · Notice · Mar 1, 2010

    Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    75 FR 9227Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ABLAVAR

    Federal Register · Notice · Jun 8, 2010

    ADDRESSES: Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    75 FR 32479Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR

    Federal Register · Notice · Apr 14, 2010

    Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    75 FR 19406Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; SAVELLA

    Federal Register · Notice · Apr 14, 2010

    Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    75 FR 19407Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; Synercid

    Federal Register · Notice · Sep 21, 2001

    Submit electronic comments to http://www.fda.gov/dockets/ecomments. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    66 FR 48690Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; VESICARE

    Federal Register · Notice · Mar 23, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective : May 5, 1999.

    71 FR 14708Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; EMEND

    Federal Register · Notice · Aug 3, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : May 10, 1996.

    71 FR 44033Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ELAPRASE

    Federal Register · Notice · May 23, 2007

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : January 25, 2001.

    72 FR 28980Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; SOMAVERT

    Federal Register · Notice · May 24, 2007

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : April 18, 1997.

    72 FR 29172Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; EMTRIVA

    Federal Register · Notice · Mar 26, 2007

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : September 19, 1997.

    72 FR 14122Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; A180

    Federal Register · Notice · Mar 27, 2007

    Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

    72 FR 14280Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ALOXI

    Federal Register · Notice · Feb 2, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective : December 24, 1992.

    71 FR 5668Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; PLENAXIS

    Federal Register · Notice · Sep 29, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : November 17, 1996.

    71 FR 57545Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; APTIVUS

    Federal Register · Notice · Sep 20, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : December 14, 1996.

    71 FR 54995Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ROZEREM

    Federal Register · Notice · Jun 19, 2006

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : June 22, 1999.

    71 FR 35274Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; LEXAPRO

    Federal Register · Notice · Dec 2, 2003

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : June 27, 1999.

    68 FR 67455Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; FROVA

    Federal Register · Notice · Jan 29, 2004

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : November 1, 1995.

    69 FR 4305Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; REMODULIN

    Federal Register · Notice · Jan 29, 2004

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : May 15, 1991.

    69 FR 4306Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; EXTRANAEAL

    Federal Register · Notice · Feb 6, 2004

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: December 6, 1996.

    69 FR 5858Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ABILIFY

    Federal Register · Notice · Nov 26, 2003

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective : July 11, 1993.

    68 FR 66449Health and Human Services DepartmentFood and Drug Administration

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