Nonrulemaking

Requests that FDA determine that the proposed new strength, Ertapenem for Injection, 500 mg/vial, developed by Qilu Antibiotics Pharmaceutical Co., Ltd., is suitable for submission in an Abbreviated New Drug Application (ANDA)

🏛 Food and Drug Administration (FDA)FDA-2026-P-7530

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 22, 2026

Completeness Assessment Correspondence

No comment period

Other· Jul 7, 2026
Suitability Petition from Qilu Pharma, Inc.→
No comment period
Other· Jul 7, 2026
Acknowledgment Letter from FDA DMB to Qilu Pharma, Inc→
No comment period
Supporting & Related Material· Jul 7, 2026
Attachment 1 - Relevant page from the current Electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for INVANZ→
Supporting & Related Material· Jul 7, 2026
Attachment 2 - Approved package insert for the reference listed drug, INVANZ→
Supporting & Related Material· Jul 7, 2026
Attachment 3 - Qilu’s proposed package insert→