← FDA DRUG APPROVALS

FDA NDA · NDA215212

MEROPENEM

Sponsor: HQ SPCLT PHARMA

APPLICATION
NDA215212
TYPE
NDA
ORIGINAL APPROVAL
2023-07-26
LATEST ACTION
2024-12-03
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

MEROPENEM · ReferencePrescription
MEROPENEM 2GM/VIAL · POWDER · INTRAVENOUS

Approval history

2024-12-03Labeling · Supplement 2 · standardLetterAP
2023-07-26Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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