← FDA DRUG APPROVALS

FDA NDA · NDA216755

LIKMEZ

metronidazole oral

Sponsor: SAPTALIS PHARMS

APPLICATION
NDA216755
TYPE
NDA
ORIGINAL APPROVAL
2023-09-22
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

LIKMEZ · ReferencePrescription
METRONIDAZOLE 500MG/5ML · SUSPENSION · ORAL

Approval history

2025-02-28Labeling · Supplement 4 · standard — Label ↗AP
2024-07-08Labeling · Supplement 3 · standard — Label ↗AP
2024-05-14Labeling · Supplement 1 · standard — Label ↗AP
2023-09-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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