APPLICATION
ANDA065421
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-22
LATEST ACTION
2025-04-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
RIFAMPINPrescription
RIFAMPIN 600MG/VIAL · INJECTABLE · INJECTION
Approval history
2025-04-03Labeling · Supplement 29 · standardAP
2024-02-15Labeling · Supplement 19 · standardAP
2024-02-15Labeling · Supplement 23 · standardAP
2024-02-15Labeling · Supplement 21 · standardAP
2024-02-15Labeling · Supplement 26 · standardAP
2024-02-15Labeling · Supplement 18 · standardAP
2020-07-01Labeling · Supplement 9 · standardAP
2020-07-01Labeling · Supplement 8 · standardAP
2020-07-01Labeling · Supplement 14 · standardAP
2015-10-27Labeling · Supplement 3 · standardAP
2008-05-22OriginalAP
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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