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FDA NDA · NDA018421

LITHIUM CITRATE

Sponsor: HIKMA

APPLICATION
NDA018421
TYPE
NDA
ORIGINAL APPROVAL
1980-12-23
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

LITHIUM CITRATE · ReferenceDiscontinued
LITHIUM CITRATE EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL

Approval history

2022-10-13Labeling · Supplement 35 · standard — Letter ↗AP
2020-02-05Labeling · Supplement 33 · 901 required — Letter ↗AP
2018-12-20Labeling · Supplement 32 · standard — Letter ↗AP
2018-10-04Labeling · Supplement 31 · standard — Letter ↗AP
2016-10-25Labeling · Supplement 25 · standard — Letter ↗AP
2015-06-12Manufacturing (CMC) · Supplement 29 · standardAP
2014-07-01Manufacturing (CMC) · Supplement 28 · standardAP
2011-10-20Labeling · Supplement 27 · 901 required — Letter ↗AP
2003-01-31Labeling · Supplement 21 · standard — Letter ↗AP
2002-11-08Manufacturing (CMC) · Supplement 22 · standardAP
2001-11-26Labeling · Supplement 16 · standard — Letter ↗AP
2001-11-26Labeling · Supplement 14 — Letter ↗AP
2001-11-26Labeling · Supplement 15 · standard — Letter ↗AP
1999-08-06Manufacturing (CMC) · Supplement 20 · standardAP
1999-07-29Manufacturing (CMC) · Supplement 19 · standardAP
1997-06-16Manufacturing (CMC) · Supplement 18 · standardAP
1997-06-16Manufacturing (CMC) · Supplement 17 · standardAP
1989-11-26Labeling · Supplement 13 — Letter ↗AP
1988-06-28Manufacturing (CMC) · Supplement 12 · standardAP
1987-11-26Labeling · Supplement 11 — Letter ↗AP
1987-09-29Manufacturing (CMC) · Supplement 9 · standardAP
1984-07-23Manufacturing (CMC) · Supplement 7 · standardAP
1983-03-24Labeling · Supplement 6AP
1983-01-31Labeling · Supplement 4AP
1982-04-29Manufacturing (CMC) · Supplement 2 · standardAP
1981-05-04Manufacturing (CMC) · Supplement 1 · standardAP
1980-12-23Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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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