APPLICATION
ANDA070755
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-21
LATEST ACTION
2022-10-13
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
LITHIUM CITRATEPrescription
LITHIUM CITRATE EQ 300MG CARBONATE/5ML · SYRUP · ORAL
Approval history
2022-10-13Labeling · Supplement 15 · standardAP
2022-10-13Labeling · Supplement 14 · standardAP
2008-04-28Labeling · Supplement 13AP
1997-04-22Labeling · Supplement 9AP
1996-02-05Labeling · Supplement 8AP
1994-08-12Labeling · Supplement 7AP
1994-08-12Labeling · Supplement 18AP
1990-08-29Labeling · Supplement 6AP
1989-03-27Labeling · Supplement 5AP
1987-03-25Manufacturing (CMC) · Supplement 4AP
1987-03-25Manufacturing (CMC) · Supplement 3AP
1987-02-17Labeling · Supplement 2AP
1986-11-10Labeling · Supplement 1AP
1986-05-21OriginalAP
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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