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
2017_register
executive
2018-10-25
article
Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
D09002ee1bdba72ac
D09002ee1bdba730d
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and Drug Administration (FDA or Agency) has determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for norfloxacin tablets, 400 mg, if all other legal and regulatory requirements are met.
82 FR 58421
https://www.govinfo.gov/app/details/FR-2017-12-12/2017-26693
2017-26693
fr12de17-44
4164-01-P
Docket No. FDA-2017-P-2659
https://www.govinfo.gov/app/details/FR-2017-12-12/2017-26693
https://www.govinfo.gov/content/pkg/FR-2017-12-12/html/2017-26693.htm
https://www.govinfo.gov/content/pkg/FR-2017-12-12/pdf/2017-26693.pdf
1 p.
58421
58421
82 FR 58421
Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 82, Issue
NOTICE
2017-26693
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-P-2659
4164-01-P
2017-26693
Notice.
The Food and Drug Administration (FDA or Agency) has determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for norfloxacin tablets, 400 mg, if all other legal and regulatory requirements are met.
Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 240- 402-0978.
Determinations that Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:
NOROXIN (Norfloxacin) Tablets, 400 Milligrams
,
Federal Register
Vol. 82, no. 237
Office of the Federal Register, National Archives and Records Administration
2017-12-12
continuing
daily
deposited
born digital
208 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-12-12
P0b002ee19d7bdc9f
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr12de17
https://www.govinfo.gov/app/details/FR-2017-12-12
https://www.govinfo.gov/content/pkg/FR-2017-12-12/pdf/FR-2017-12-12.pdf
https://www.govinfo.gov/content/pkg/FR-2017-12-12/xml/FR-2017-12-12.xml
fdlp
58333
58532
DGPO
2018-10-25
2023-04-28
FR-2017-12-12
machine generated
eng
FR
FR-2017-12-12
82
237