Nonrulemaking

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.

🏛 Food and Drug Administration (FDA)FDA-2026-P-8515

Pharmaceutical Policy

Documents

5

Total comments

0

all analyzed

Comment status

Open

Last activity

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In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

All 5 Supporting & Related Material 3 Other 2

📄 Primary document

OtherJul 31, 2026

Suitability Petition from Lachman Consulting Services, Inc.

No comment period

Other· Jul 31, 2026
Acknowledgment Letter from FDA DMB to Lachman Consulting Services, Inc.→
No comment period
Supporting & Related Material· Jul 31, 2026
Attachment 1 - Copy of the relevant excerpt from the current electronic Edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)→
Supporting & Related Material· Jul 31, 2026
Attachment 2 - Current Package Insert for Meropenem for Injection and Sodium Chloride Injection, 1 g/Duplex container, Revision 12/2024; source: Drugs@FDA→
Supporting & Related Material· Jul 31, 2026
Attachment 3 - Draft Package Insert Proposed for Meropenem for Injection and Sodium Chloride Injection 2 g/ Dual-Mix® container.→