APPLICATION
ANDA061884
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-11
LATEST ACTION
2019-09-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIFAMATEDiscontinued
ISONIAZID 150MG, RIFAMPIN 300MG · CAPSULE · ORAL
Approval history
2019-09-27Labeling · Supplement 22 · standardAP
2019-09-27Labeling · Supplement 20 · standardAP
2019-09-27Labeling · Supplement 19 · standardAP
2019-09-27Labeling · Supplement 25 · standardAP
2019-09-27Labeling · Supplement 18 · standardAP
2013-07-22Labeling · Supplement 17AP
2013-07-22Labeling · Supplement 15AP
1999-08-27Labeling · Supplement 10AP
1994-08-19Manufacturing (CMC) · Supplement 12AP
1991-12-09Manufacturing (CMC) · Supplement 9AP
1975-07-11OriginalAP
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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