APPLICATION
ANDA090034
TYPE
ANDA
ORIGINAL APPROVAL
2013-08-21
LATEST ACTION
2023-08-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
RIFAMPINPrescription
RIFAMPIN 300MG · CAPSULE · ORAL
RIFAMPINPrescription
RIFAMPIN 150MG · CAPSULE · ORAL
Approval history
2023-08-16Labeling · Supplement 22 · standardAP
2023-06-30Labeling · Supplement 21 · standardAP
2022-08-30Labeling · Supplement 18 · standardAP
2022-08-30Labeling · Supplement 17 · standardAP
2021-09-14Labeling · Supplement 15 · standardAP
2020-08-17Labeling · Supplement 13 · standardAP
2020-03-31Labeling · Supplement 11 · standardAP
2020-03-31Labeling · Supplement 8 · standardAP
2020-03-31Labeling · Supplement 12 · standardAP
2020-03-31Labeling · Supplement 10 · standardAP
2020-03-31Labeling · Supplement 9 · standardAP
2013-08-21OriginalAP
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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