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Attachment - 1-Orange Book-RLD

FDA-2026-P-7195-0003Supporting & Related Material
Document

Details

The document's own metadata, straight from the source system.

Title
Attachment - 1-Orange Book-RLD
Posted
Jun 30, 2026
Agency
Food and Drug Administration (FDA)
Topics
  • Pharmaceutical Policy
View on regulations.gov ↗
Related

Related documents

Other documents filed with this rulemaking.

View related documents
Other
Completeness Assessment Correspondence
No comment periodJul 16, 2026
Supporting & Related Material
Attachment-2-Orange Book-tablets
No comment periodJun 30, 2026
Supporting & Related Material
Attachment-5-proposed labeling
No comment periodJun 30, 2026
Other
Suitability Petition from Senores Pharmaceuticals, Inc
No comment periodJun 30, 2026
Other
Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc
No comment periodJun 30, 2026
Supporting & Related Material
Attachment-3-Prescribing Information-RS
No comment periodJun 30, 2026
Supporting & Related Material
Attachment-4-Prescribing Information-RLD
No comment periodJun 30, 2026

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