APPLICATION
NDA012193
TYPE
NDA
ORIGINAL APPROVAL
1960-02-11
LATEST ACTION
1992-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SER-AP-ESDiscontinued
HYDRALAZINE HYDROCHLORIDE 25MG, HYDROCHLOROTHIAZIDE 15MG, RESERPINE 0.1MG · TABLET · ORAL
Approval history
1992-02-28Manufacturing (CMC) · Supplement 66 · standardAP
1983-07-08Labeling · Supplement 56AP
1960-02-11Type 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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