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OMB control number

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

OMB 0910-0530 · HHS/FDA.

OMB 0910-0530
Latest Forms, Documents, and Supporting Material
Document
Name
SUPPORTING STATEMENT 0530 FINAL 9-11-13.doc
Supporting Statement A
Content of Labeling Submissions in NDAs, ANDAs, Supplemental NDAs and ANDAs, and Annual Reports
All Historical Document Collections
201309-0910-009
Approved without change
Extension without change of a currently approved collection 2013-09-19
201008-0910-003
Approved without change
Reinstatement without change of a previously approved collection 2010-08-09
201005-0910-007
Improperly submitted and continue
Extension without change of a currently approved collection 2010-05-18
200702-0910-001
Approved without change
Extension without change of a currently approved collection 2007-02-08
200311-0910-005
Approved without change
New collection (Request for a new OMB Control Number) 2003-11-21

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