APPLICATION
ANDA070346
TYPE
ANDA
ORIGINAL APPROVAL
1986-01-22
LATEST ACTION
2004-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMILORIDE HYDROCHLORIDEPrescription
AMILORIDE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2004-06-18Labeling · Supplement 12AP
2002-09-16Labeling · Supplement 11AP
2001-06-07Manufacturing (CMC) · Supplement 10AP
1997-11-26Manufacturing (CMC) · Supplement 8AP
1997-11-26Manufacturing (CMC) · Supplement 9AP
1989-10-24Labeling · Supplement 7AP
1989-05-19Labeling · Supplement 6AP
1987-10-05Manufacturing (CMC) · Supplement 4AP
1986-05-16Manufacturing (CMC) · Supplement 1AP
1986-01-22OriginalAP
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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