APPLICATION
ANDA088587
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-02
LATEST ACTION
2001-10-25
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
HYDROCHLOROTHIAZIDE · ReferenceDiscontinued
HYDROCHLOROTHIAZIDE 50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
Approval history
2001-10-25Labeling · Supplement 12AP
1999-09-14Manufacturing (CMC) · Supplement 11AP
1996-08-28Manufacturing (CMC) · Supplement 10AP
1996-03-28Manufacturing (CMC) · Supplement 9AP
1994-07-06Manufacturing (CMC) · Supplement 7AP
1994-06-28Labeling · Supplement 8AP
1993-03-01Labeling · Supplement 6AP
1990-04-05Labeling · Supplement 5AP
1988-04-21Manufacturing (CMC) · Supplement 3AP
1988-04-21Manufacturing (CMC) · Supplement 4AP
1984-07-02OriginalAP
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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