APPLICATION
ANDA070347
TYPE
ANDA
ORIGINAL APPROVAL
1986-08-06
LATEST ACTION
1996-05-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
HYDRO-RIDEDiscontinued
AMILORIDE HYDROCHLORIDE EQ 5MG ANHYDROUS, HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
Approval history
1996-05-13Manufacturing (CMC) · Supplement 11AP
1996-05-13Labeling · Supplement 12AP
1996-04-24Labeling · Supplement 10AP
1995-03-28Labeling · Supplement 9AP
1995-01-05Labeling · Supplement 8AP
1992-09-10Labeling · Supplement 7AP
1987-10-27Manufacturing (CMC) · Supplement 4AP
1987-10-27Manufacturing (CMC) · Supplement 5AP
1986-08-06OriginalAP
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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