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
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Rules, notices, and supporting material — the primary rule pinned first.
- Supporting & Related Material· Jul 7, 2026
- Supporting & Related Material· Jul 7, 2026
- Supporting & Related Material· Jul 7, 2026