Documents

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

5,436 results

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

    Federal Register · Notice · Mar 6, 2009

    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.

    74 FR 9823Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ALTABAX OINTMENT

    Federal Register · Notice · Mar 9, 2009

    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.

    74 FR 10055Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; CLEVIPREX

    Federal Register · Notice · Oct 1, 2009

    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.

    74 FR 50801Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; FANAPT

    Federal Register · Notice · Apr 6, 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 17415Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ

    Federal Register · Notice · Apr 6, 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 17414Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; GEODON

    Federal Register · Notice · Apr 29, 2005

    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 3, 1990.

    70 FR 22341Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; MULTIHANCE

    Federal Register · Notice · Jul 11, 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) became effective : July 12, 1994.

    71 FR 39120Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; BONIVA

    Federal Register · Notice · Jun 22, 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) became effective: May 15, 1996.

    71 FR 35918Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; CIALIS

    Federal Register · Notice · Jun 22, 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) became effective : July 29, 1998.

    71 FR 35919Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; PRIALT

    Federal Register · Notice · Mar 15, 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 : August 4, 1994.

    71 FR 13409Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE-New Drug Application 21-754

    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 : March 29, 1998.

    71 FR 54994Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE

    Federal Register · Notice · Mar 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 : March 29, 1998.

    71 FR 13979Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; ALAMAST

    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 : March 7, 1996.

    71 FR 14707Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; INCRELEX

    Federal Register · Notice · Jun 13, 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 13, 1992.

    71 FR 34135Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; LUVERIS

    Federal Register · Notice · Jun 13, 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 : January 9, 1994.

    71 FR 34136Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; STRATTERA

    Federal Register · Notice · Dec 3, 2003

    Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 1, 2004.

    68 FR 67678Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; INVANZ

    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. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 1, 2004.

    68 FR 67457Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; LEVULAN KERASTICK

    Federal Register · Notice · Apr 1, 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 : January 2, 1993.

    68 FR 15730Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; TRACLEER

    Federal Register · Notice · May 7, 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 : December 8, 1995.

    68 FR 24485Health and Human Services DepartmentFood and Drug Administration
  • Determination of Regulatory Review Period for Purposes of Patent Extension; COMTAN

    Federal Register · Notice · May 22, 2002

    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 : October 6, 1991.

    67 FR 36008Health and Human Services DepartmentFood and Drug Administration

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