All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-8515
Request that the FDA declare that the proposed drug product, Meropenem for Injection and Sodium Chloride Injection, 2 g in Dual-Mix® Container is suitable for submission as an ANDA.
Documents
5
Comments
0
Description
OPEN
Key Dates
Comment Period OpensJul 31, 2026
Documents
| Type | Title | Status |
|---|---|---|
Supporting Material |
Keywords
CDER
Suitability Petition
Lachman Consulting Services, Inc.
declare that the proposed drug product
Meropenem for Injection and Sodium
Chloride Injection, 2 g in Dual-Mix Container
is suitable for submission as an ANDA
OPEN
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