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Subpart C - Abbreviated Applications
Applications for FDA Approval to Market a New Drug
OMB: 0910-0001
IC ID: 184600
OMB.report
HHS/FDA
OMB 0910-0001
ICR 202209-0910-003
IC 184600
( )
Documents and Forms
Document Name
Document Type
GFI Good-ANDA-Submission-Practices-Guidance-for-Industry JAN 2018.pdf
www.fda.gov/regulatory-information/search-fda-guidance-documents/good-anda-submission-practices-guidance-industry
Other-Agency Guidance
Information Collection (IC) Details
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