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FDA NDA · NDA204508

CLINOLIPID

olive oil and soybean oil

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA204508
TYPE
NDA
ORIGINAL APPROVAL
2013-10-03
LATEST ACTION
2025-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
EMULSION
MARKETING STATUS
Prescription

Products

CLINOLIPID 20% · ReferencePrescription
OLIVE OIL 16%(160GM/1000ML), SOYBEAN OIL 4% (40GM/1000ML) · EMULSION · INTRAVENOUS

Approval history

2025-07-24Labeling · Supplement 26 · standard — Letter ↗AP
2024-04-24Efficacy · Supplement 22 · standard — Letter ↗AP
2023-05-17Labeling · Supplement 19 · standard — Label ↗AP
2023-05-17Labeling · Supplement 21 · standard — Label ↗AP
2021-04-13Labeling · Supplement 15 · standard — Letter ↗AP
2017-01-09Manufacturing (CMC) · Supplement 6 · standardAP
2016-07-20Labeling · Supplement 5 · standard — Label ↗AP
2016-02-08Manufacturing (CMC) · Supplement 4 · priorityAP
2014-11-26Manufacturing (CMC) · Supplement 3 · priorityAP
2014-08-20Manufacturing (CMC) · Supplement 2 · priorityAP
2014-06-06Manufacturing (CMC) · Supplement 1 · priorityAP
2013-10-03Type 5 - New Formulation or New Manufacturer · Original · priority — Review ↗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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