APPLICATION
NDA008662
TYPE
NDA
ORIGINAL APPROVAL
1952-09-29
LATEST ACTION
2025-02-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NYDRAZIDDiscontinued
ISONIAZID 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-06-19Manufacturing (CMC) · Supplement 18 · standardAP
2002-02-05Manufacturing (CMC) · Supplement 17 · standardAP
2001-05-25Manufacturing (CMC) · Supplement 16 · standardAP
1997-08-08Labeling · Supplement 15 · standardAP
1992-12-31Manufacturing (CMC) · Supplement 14 · standardAP
1988-06-14Labeling · Supplement 10AP
1986-11-10Labeling · Supplement 11AP
1985-07-23Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-17Labeling · Supplement 9AP
1978-05-15Labeling · Supplement 8AP
1976-05-28Labeling · Supplement 6AP
1952-09-29Type 3 - New Dosage Form · 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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