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
2019_register
executive
2019-05-30
article
Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
D09002ee1bdb763a9
D09002ee1bdb7640a
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or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
84 FR 25060
https://www.govinfo.gov/app/details/FR-2019-05-30/2019-11243
2019-11243
fr30my19-43
4164-01-P
Docket No. FDA-2018-P-4851
https://www.govinfo.gov/app/details/FR-2019-05-30/2019-11243
https://www.govinfo.gov/content/pkg/FR-2019-05-30/html/2019-11243.htm
https://www.govinfo.gov/content/pkg/FR-2019-05-30/pdf/2019-11243.pdf
2 p.
25060
25061
84 FR 25060
Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 84, Issue
NOTICE
2019-11243
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-P-4851
4164-01-P
2019-11243
Notice.
The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Meadow Platt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301- 796-1830, Meadow.Platt@fda.hhs.gov.
Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:
LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter
,
Meadow.Platt@fda.hhs.gov
Federal Register
Vol. 84, no. 104
Office of the Federal Register, National Archives and Records Administration
2019-05-30
continuing
daily
deposited
born digital
207 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-05-30
P0b002ee1a13b48f6
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr30my19
https://www.govinfo.gov/app/details/FR-2019-05-30
https://www.govinfo.gov/content/pkg/FR-2019-05-30/pdf/FR-2019-05-30.pdf
https://www.govinfo.gov/content/pkg/FR-2019-05-30/xml/FR-2019-05-30.xml
fdlp
24973
25171
DGPO
2019-05-30
2023-04-28
FR-2019-05-30
machine generated
eng
FR
FR-2019-05-30
84
104