APPLICATION
NDA009182
TYPE
NDA
ORIGINAL APPROVAL
1953-12-04
LATEST ACTION
1996-12-23
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, SYRUP, EMULSION
MARKETING STATUS
Discontinued
Products
GANTRISIN PEDIATRICDiscontinued
SULFISOXAZOLE ACETYL EQ 500MG BASE/5ML · SUSPENSION · ORAL
GANTRISINDiscontinued
SULFISOXAZOLE ACETYL EQ 500MG BASE/5ML · SYRUP · ORAL
LIPO GANTRISINDiscontinued
SULFISOXAZOLE ACETYL EQ 1GM BASE/5ML · EMULSION · ORAL
Approval history
1996-12-23Manufacturing (CMC) · Supplement 20 · standardAP
1995-07-31Manufacturing (CMC) · Supplement 19 · standardAP
1993-08-04Labeling · Supplement 17 · standardAP
1982-05-25Labeling · Supplement 16 · standardAP
1978-01-27Labeling · Supplement 14 · standardAP
1977-12-22Manufacturing (CMC) · Supplement 13 · standardAP
1975-04-11Manufacturing (CMC) · Supplement 12 · standardAP
1953-12-04Type 2 - New Active Ingredient · 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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