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2013-03-01
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Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Notices
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United States
Department of Health and Human Services
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United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.
78 FR 14095
https://www.govinfo.gov/app/details/FR-2013-03-04/2013-04827
2013-04827
fr04mr13-50
4160-01-P
Docket No. FDA-2012-P-1071
https://www.govinfo.gov/app/details/FR-2013-03-04/2013-04827
https://www.govinfo.gov/content/pkg/FR-2013-03-04/html/2013-04827.htm
https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04827.pdf
2 p.
14095
14096
78 FR 14095
Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 78, Issue
NOTICE
2013-04827
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-P-1071
4160-01-P
2013-04827
Notice.
The Food and Drug Administration (FDA) has determined that GEREF (Sermorelin Acetate) injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, if all other legal and regulatory requirements are met.
Kathy Schreier, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6252, Silver Spring, MD 20993-0002, 301- 796-3432.
Determinations that Products were Not Withdrawn from Sale for Reasons of Safety or Effectiveness:
GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp
,
Federal Register
Vol. 78, no. 42
Office of the Federal Register, National Archives and Records Administration
2013-03-04
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165 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-03-04
P0b002ee183de480b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr04mr13
https://www.govinfo.gov/app/details/FR-2013-03-04
https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/FR-2013-03-04.pdf
https://www.govinfo.gov/content/pkg/FR-2013-03-04/xml/FR-2013-03-04.xml
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