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FDA ANDA · ANDA064217

RIFAMPIN

Sponsor: HIKMA

APPLICATION
ANDA064217
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-29
LATEST ACTION
2025-05-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RIFAMPINPrescription
RIFAMPIN 600MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-05-06Labeling · Supplement 18 · standardAP
2025-05-06Labeling · Supplement 17 · standardAP
2011-06-13Labeling · Supplement 10AP
2001-01-29Labeling · Supplement 2AP
2000-09-29Labeling · Supplement 1AP
1999-10-29OriginalReviewAP
VIEW ON DRUGS@FDA ↗

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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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