APPLICATION
ANDA091620
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-27
LATEST ACTION
2021-01-25
ROUTE
INTRAVENOUS, PARENTERAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
TIGECYCLINEPrescription
TIGECYCLINE 50MG/VIAL · POWDER · INTRAVENOUS
Approval history
2021-01-25Labeling · Supplement 10 · standardAP
2020-04-09Labeling · Supplement 7 · standardAP
2020-04-09Labeling · Supplement 6 · standardAP
2017-09-29Manufacturing (CMC) · Supplement 3AP
2017-09-29Labeling · Supplement 1 · standardAP
2017-09-29Labeling · Supplement 2 · standardAP
2015-05-27OriginalAP
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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