APPLICATION
ANDA205039
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-03
LATEST ACTION
2020-07-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
RIFAMPINPrescription
RIFAMPIN 600MG/VIAL · INJECTABLE · INJECTION
Approval history
2020-07-01Labeling · Supplement 3 · standardAP
2020-07-01Labeling · Supplement 1 · standardAP
2020-07-01Labeling · Supplement 4 · standardAP
2020-07-01Labeling · Supplement 2 · standardAP
2016-03-03UNKNOWN · 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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