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Regulatory Information
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2014-05-29
article
Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL-New Drug Applications 21-986 and 22-072
Notices
D09002ee1bddaae82
D09002ee1bddaaeef
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL--new drug applications (NDAs) 21- 986 and 22-072 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
72 FR 29334
https://www.govinfo.gov/app/details/FR-2007-05-25/E7-10089
E7-10089
fr25my07-66
4160-01-S
Docket No. 2006E-0516
https://www.govinfo.gov/app/details/FR-2007-05-25/E7-10089
https://www.govinfo.gov/content/pkg/FR-2007-05-25/html/E7-10089.htm
https://www.govinfo.gov/content/pkg/FR-2007-05-25/pdf/E7-10089.pdf
2 p.
29334
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72 FR 29334
Determination of Regulatory Review Periods for Purposes of Patent Extension; SPRYCEL-New Drug Applications 21-986 and 22-072; Federal Register Vol. 72, Issue
NOTICE
E7-10089
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2006E-0516
4160-01-S
E7-10089
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for SPRYCEL--new drug applications (NDAs) 21- 986 and 22-072 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Beverly Friedman, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
Human drugs:
Patent extension; regulatory review period determinations
SPRYCEL,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 72, no. 101
Office of the Federal Register, National Archives and Records Administration
2007-05-25
continuing
daily
deposited
born digital
204 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2007-05-25
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0042-1219
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https://www.govinfo.gov/app/details/FR-2007-05-25
https://www.govinfo.gov/content/pkg/FR-2007-05-25/pdf/FR-2007-05-25.pdf
https://www.govinfo.gov/content/pkg/FR-2007-05-25/xml/FR-2007-05-25.xml
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