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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
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📄 Primary document
OtherJul 7, 2026
Suitability Petition from Qilu Pharma, Inc.
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