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FR
Regulatory Information
2001_register
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2010-09-24
article
Determination of Regulatory Review Period for Purposes of Patent Extension; Kaletra
Notices
D09002ee1bdf66e19
D09002ee1bdf66f33
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) has determined the regulatory review period for Kaletra 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 Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
66 FR 48687
https://www.govinfo.gov/app/details/FR-2001-09-21/01-23700
01-23700
fr21se01-86
4160-01-S
Docket No. 01E-0089
https://www.govinfo.gov/app/details/FR-2001-09-21/01-23700
https://www.govinfo.gov/content/pkg/FR-2001-09-21/html/01-23700.htm
https://www.govinfo.gov/content/pkg/FR-2001-09-21/pdf/01-23700.pdf
2 p.
48687
48688
66 FR 48687
Determination of Regulatory Review Period for Purposes of Patent Extension; Kaletra; Federal Register Vol. 66, Issue
NOTICE
01-23700
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 01E-0089
4160-01-S
01-23700
Notice.
The Food and Drug Administration (FDA) has determined the regulatory review period for Kaletra 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 Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Claudia Grillo, Office of Regulatory Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5645.
Human drugs:
Patent extension; regulatory review period determinations
Kaletra,
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 66, no. 184
Office of the Federal Register, National Archives and Records Administration
2001-09-21
continuing
daily
deposited
born digital
269 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2001-09-21
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr21se01
https://www.govinfo.gov/app/details/FR-2001-09-21
https://www.govinfo.gov/content/pkg/FR-2001-09-21/pdf/FR-2001-09-21.pdf
https://www.govinfo.gov/content/pkg/FR-2001-09-21/xml/FR-2001-09-21.xml
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2010-09-24
2023-05-04
FR-2001-09-21
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FR
FR-2001-09-21
66
184