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Attachment 3 - Qilu’s proposed package insert

Supporting & Related MaterialFDA-2026-P-7530-0005
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Title
Attachment 3 - Qilu’s proposed package insert
Posted
Jul 7, 2026
Agency
Food and Drug Administration (FDA)
Topics
  • Pharmaceutical Policy
View on regulations.gov ↗
Related

Related documents

Other documents filed with this rulemaking.

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Supporting & Related Material
Attachment 1 - Relevant page from the current Electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for INVANZ
No comment periodJul 7, 2026
Supporting & Related Material
Attachment 2 - Approved package insert for the reference listed drug, INVANZ
No comment periodJul 7, 2026
Other
Suitability Petition from Qilu Pharma, Inc.
No comment periodJul 7, 2026
Other
Acknowledgment Letter from FDA DMB to Qilu Pharma, Inc
No comment periodJul 7, 2026

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