APPLICATION
NDA012148
TYPE
NDA
ORIGINAL APPROVAL
1959-12-14
LATEST ACTION
2001-09-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ORETICYL 50Discontinued
DESERPIDINE 0.125MG, HYDROCHLOROTHIAZIDE 50MG · TABLET · ORAL
ORETICYL 25Discontinued
DESERPIDINE 0.125MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
ORETICYL FORTEDiscontinued
DESERPIDINE 0.25MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
Approval history
2001-09-17Labeling · Supplement 6AP
1994-02-16Labeling · Supplement 18AP
1994-02-16Labeling · Supplement 14AP
1994-02-16Labeling · Supplement 19AP
1984-02-08Labeling · Supplement 16AP
1979-08-20Labeling · Supplement 8AP
1979-08-20Labeling · Supplement 10AP
1959-12-14Type 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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