Nonrulemaking

Request that the FDA determine and declare that Metformin Tablets 375 mg and 425 mg are suitable for submission in an Abbreviated New Drug Application (ANDA)

🏛 Food and Drug Administration (FDA)FDA-2026-P-7602

Pharmaceutical Policy

Documents

7

Total comments

0

all analyzed

Comment status

Open

Last activity

—

In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 7 Supporting & Related Material 4 Other 3

📄 Primary document

OtherJul 27, 2026

Completeness Assessment Correspondence to Senores Pharmaceuticals, Inc.

No comment period

Other· Jul 8, 2026
Suitability Petition from Senores Pharmaceuticals, Inc→
No comment period
Other· Jul 8, 2026
Acknowledgment Letter from FDA DMB to Senores Pharmaceuticals, Inc→
No comment period
Supporting & Related Material· Jul 8, 2026
Attachment 1-Orange Book Pages→
Supporting & Related Material· Jul 8, 2026
Attachment 2-Reference Standard approved labeling→
Supporting & Related Material· Jul 8, 2026
Attachment 3-Prescribing Information-GLUCOPHAGE→
Supporting & Related Material· Jul 8, 2026
Attachment 4-Draft labeling for the proposed drug product→