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FDA NDA · NDA022536

INDOMETHACIN

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA022536
TYPE
NDA
ORIGINAL APPROVAL
2010-03-17
LATEST ACTION
2021-12-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

INDOMETHACIN · ReferencePrescription
INDOMETHACIN EQ 1MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2021-12-21Labeling · Supplement 8 · standard — Label ↗AP
2015-06-05Manufacturing (CMC) · Supplement 4 · standardAP
2010-03-17Type 5 - New Formulation or New Manufacturer · Original · standard — Summary 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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