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Attachment 2-Reference Standard approved labeling

Supporting & Related MaterialFDA-2026-P-7602-0004
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Title
Attachment 2-Reference Standard approved labeling
Posted
Jul 8, 2026
Agency
Food and Drug Administration (FDA)
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Related

Related documents

Other documents filed with this rulemaking.

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Other
Suitability Petition from Senores Pharmaceuticals, Inc
No comment periodJul 8, 2026
Other
Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc
No comment periodJul 8, 2026
Supporting & Related Material
Attachment 1-Orange Book Pages
No comment periodJul 8, 2026
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Attachment 4-Draft labeling for the proposed drug product
No comment periodJul 8, 2026
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Attachment 3-Prescribing Information-GLUCOPHAGE
No comment periodJul 8, 2026

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