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2013-11-06
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Determination That MOBAN (Molindone Hydrochloride) Tablets (5 Milligrams, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams) and Capsules (5 Milligrams, 10 Milligrams, and 25 Milligrams) Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 Government Agency or Subagency
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 MOBAN (molindone hydrochloride (HCl)) tablets (5 milligrams (mg), 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) if all other legal and regulatory requirements are met.
78 FR 66742
https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26550
2013-26550
fr06no13-41
4160-01-P
Docket No. FDA-2013-P-0631
https://www.govinfo.gov/app/details/FR-2013-11-06/2013-26550
https://www.govinfo.gov/content/pkg/FR-2013-11-06/html/2013-26550.htm
https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/2013-26550.pdf
2 p.
66742
66743
78 FR 66742
Determination That MOBAN (Molindone Hydrochloride) Tablets (5 Milligrams, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams) and Capsules (5 Milligrams, 10 Milligrams, and 25 Milligrams) Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Federal Register Vol. 78, Issue
NOTICE
2013-26550
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-P-0631
4160-01-P
2013-26550
Notice.
The Food and Drug Administration (FDA) has determined that MOBAN (molindone hydrochloride (HCl)) tablets (5 milligrams (mg), 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) if all other legal and regulatory requirements are met.
Emily Helms Williams, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 301- 796-3381.
Determination that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness:
MOBAN (Molindone Hydrochloride); Tablets (5, 10, 25, 50, and 100 mg) and Capsules (5, 10, and 25 mg)
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Federal Register
Vol. 78, no. 215
Office of the Federal Register, National Archives and Records Administration
2013-11-06
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-11-06
P0b002ee18650170b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr06no13
https://www.govinfo.gov/app/details/FR-2013-11-06
https://www.govinfo.gov/content/pkg/FR-2013-11-06/pdf/FR-2013-11-06.pdf
https://www.govinfo.gov/content/pkg/FR-2013-11-06/xml/FR-2013-11-06.xml
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66824
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2013-11-06
2023-04-30
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