United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2007_register
executive
2010-09-22
article
Determination That DURICEF (Cefadroxil USP) Tablets, 1 Gram, and Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
D09002ee1bddb6537
D09002ee1bddb65dd
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(FDA) has determined that DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 g, and cefadroxil USP capsules, 500 mg.
72 FR 14118
https://www.govinfo.gov/app/details/FR-2007-03-26/E7-5415
E7-5415
fr26mr07-61
4160-01-S
Docket No. 2006P-0255
https://www.govinfo.gov/app/details/FR-2007-03-26/E7-5415
https://www.govinfo.gov/content/pkg/FR-2007-03-26/html/E7-5415.htm
https://www.govinfo.gov/content/pkg/FR-2007-03-26/pdf/E7-5415.pdf
1 p.
14118
14118
72 FR 14118
Determination That DURICEF (Cefadroxil USP) Tablets, 1 Gram, and Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 72, Issue
NOTICE
E7-5415
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 2006P-0255
4160-01-S
E7-5415
Notice.
The Food and Drug Administration (FDA) has determined that DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to continue to approve abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 g, and cefadroxil USP capsules, 500 mg.
Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
Human drugs:
Drug products withdrawn from sale for reasons other than safety or effectiveness
DURICEF (cefadroxil USP) tablets, 1 gram, and capsules, 500 milligrams,
Federal Register
Vol. 72, no. 57
Office of the Federal Register, National Archives and Records Administration
2007-03-26
continuing
daily
deposited
born digital
214 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2007-03-26
P0b002ee18096108e
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr26mr07
https://www.govinfo.gov/app/details/FR-2007-03-26
https://www.govinfo.gov/content/pkg/FR-2007-03-26/pdf/FR-2007-03-26.pdf
https://www.govinfo.gov/content/pkg/FR-2007-03-26/xml/FR-2007-03-26.xml
fdlp
14035
14233
DGPO
2010-09-22
2023-05-02
FR-2007-03-26
machine generated
eng
FR
FR-2007-03-26
72
57