← FDA DRUG APPROVALS

FDA NDA · NDA020793

CAFFEINE CITRATE

Sponsor: HIKMA

APPLICATION
NDA020793
TYPE
NDA
ORIGINAL APPROVAL
1999-09-21
LATEST ACTION
2020-03-02
ROUTE
INTRAVENOUS, ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

CAFCIT · ReferencePrescription
CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
CAFCIT · ReferenceDiscontinued
CAFFEINE CITRATE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2020-03-02Labeling · Supplement 19 · standard — Letter ↗AP
2014-12-23Manufacturing (CMC) · Supplement 16 · priorityAP
2010-06-11Labeling · Supplement 9 · unknown — Letter ↗AP
2002-03-08Manufacturing (CMC) · Supplement 5 · priorityAP
2002-02-08Labeling · Supplement 4 · standard — Letter ↗AP
2002-01-18Labeling · Supplement 3 · standard — Letter ↗AP
2000-04-14Manufacturing (CMC) · Supplement 2 · priorityAP
2000-04-12Efficacy · Supplement 1 · standard — Letter ↗AP
1999-09-21Type 2 - New Active Ingredient · 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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