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
2016_register
executive
2016-07-14
article
Determination That PARAFON FORTE DSC (Chlorzoxazone) Tablets, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
D09002ee1c2c62863
D09002ee1c2c628e6
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(FDA or Agency) has determined that PARAFON FORTE DSC (chlorzoxazone) tablets, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.
81 FR 45507
https://www.govinfo.gov/app/details/FR-2016-07-14/2016-16635
2016-16635
fr14jy16-70
4164-01-P
Docket No. FDA-2015-P-4224
https://www.govinfo.gov/app/details/FR-2016-07-14/2016-16635
https://www.govinfo.gov/content/pkg/FR-2016-07-14/html/2016-16635.htm
https://www.govinfo.gov/content/pkg/FR-2016-07-14/pdf/2016-16635.pdf
1 p.
45507
45507
81 FR 45507
Determination That PARAFON FORTE DSC (Chlorzoxazone) Tablets, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 81, Issue
NOTICE
2016-16635
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2015-P-4224
4164-01-P
2016-16635
Notice.
The Food and Drug Administration (FDA or Agency) has determined that PARAFON FORTE DSC (chlorzoxazone) tablets, 500 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and this determination will allow FDA to continue to approve ANDAs for chlorzoxane tablets, 500 mg, if all other legal and regulatory requirements are met.
David Faranda, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301- 796-8767.
Determinations That Products Were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:
PARAFON FORTE DSC (Chlorzoxazone) Tablets, 500 Milligrams
,
Federal Register
Vol. 81, no. 135
Office of the Federal Register, National Archives and Records Administration
2016-07-14
continuing
daily
deposited
born digital
585 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-07-14
P0b002ee1904166b3
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr14jy16
https://www.govinfo.gov/app/details/FR-2016-07-14
https://www.govinfo.gov/content/pkg/FR-2016-07-14/pdf/FR-2016-07-14.pdf
https://www.govinfo.gov/content/pkg/FR-2016-07-14/xml/FR-2016-07-14.xml
fdlp
45387
45962
DGPO
2016-07-14
2023-12-08
FR-2016-07-14
machine generated
eng
FR
FR-2016-07-14
81
135