APPLICATION
ANDA204439
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2025-08-06
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
TIGECYCLINEPrescription
TIGECYCLINE 50MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-08-06Labeling · Supplement 7 · standardAP
2021-02-01Labeling · Supplement 3 · standardAP
2018-12-21UNKNOWN · OriginalAP
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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