Nonrulemaking

Requests that FDA declare that Cyclobenzaprine HCl Sublingual Tablets, 5.6 mg, is suitable for submission as an ANDA

🏛 Food and Drug Administration (FDA)FDA-2026-P-7610

Pharmaceutical Policy

Documents

6

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 6 Other 3 Supporting & Related Material 3

📄 Primary document

OtherJul 29, 2026

Completeness Assessment Correspondence

No comment period

Other· Jul 8, 2026
Suitability Petition from Hyman, Phelps & McNamara, P.C.→
No comment period
Other· Jul 8, 2026
Acknowledgement Letter from FDA DMB to Hyman, Phelps & McNamara, P.C.→
No comment period
Supporting & Related Material· Jul 8, 2026
Attachment 1→
Supporting & Related Material· Jul 8, 2026
Attachment 2→
Supporting & Related Material· Jul 8, 2026
Attachment 3→