APPLICATION
NDA018201
TYPE
NDA
ORIGINAL APPROVAL
1981-10-05
LATEST ACTION
2003-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MODURETIC 5-50 · ReferenceDiscontinued
AMILORIDE HYDROCHLORIDE EQ 5MG ANHYDROUS, HYDROCHLOROTHIAZIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-06-24Manufacturing (CMC) · Supplement 39 · standardAP
2002-04-05Manufacturing (CMC) · Supplement 38 · standardAP
2001-09-18Labeling · Supplement 36 · standardAP
1998-08-24Labeling · Supplement 34 · standardAP
1998-02-12Manufacturing (CMC) · Supplement 35 · standardAP
1995-11-29Manufacturing (CMC) · Supplement 33 · standardAP
1993-12-09Labeling · Supplement 32 · standardAP
1992-10-01Labeling · Supplement 31 · standardAP
1992-09-17Labeling · Supplement 30 · standardAP
1992-03-26Manufacturing (CMC) · Supplement 29 · standardAP
1991-05-14Manufacturing (CMC) · Supplement 26 · standardAP
1989-04-12Labeling · Supplement 25 · standardAP
1988-08-15Manufacturing (CMC) · Supplement 18 · standardAP
1988-05-05Labeling · Supplement 15 · standardAP
1988-04-21Manufacturing (CMC) · Supplement 23 · standardAP
1988-03-29Manufacturing (CMC) · Supplement 24 · standardAP
1987-08-26Labeling · Supplement 19 · standardAP
1987-07-10Manufacturing (CMC) · Supplement 22 · standardAP
1987-06-01Manufacturing (CMC) · Supplement 21 · standardAP
1987-03-09Manufacturing (CMC) · Supplement 20 · standardAP
1986-07-16Labeling · Supplement 12 · standardAP
1986-01-21Labeling · Supplement 17 · standardAP
1985-11-01Labeling · Supplement 16 · standardAP
1985-09-10Manufacturing (CMC) · Supplement 14 · standardAP
1985-06-14Labeling · Supplement 13 · standardAP
1985-02-07Labeling · Supplement 11 · standardAP
1984-08-28Labeling · Supplement 10 · standardAP
1984-04-19Labeling · Supplement 9 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 7 · standardAP
1983-12-23Manufacturing (CMC) · Supplement 6 · standardAP
1983-03-01Manufacturing (CMC) · Supplement 5 · standardAP
1982-07-08Manufacturing (CMC) · Supplement 4 · standardAP
1982-06-04Manufacturing (CMC) · Supplement 3 · standardAP
1982-03-03Manufacturing (CMC) · Supplement 2 · standardAP
1982-02-08Manufacturing (CMC) · Supplement 1 · standardAP
1981-10-05Type 4 - New Combination · Original · standardAP
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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