APPLICATION
ANDA062992
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-16
LATEST ACTION
2025-04-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
DOXYCYCLINE HYCLATEPrescription
DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-04-08Labeling · Supplement 9 · standardAP
2020-05-05Labeling · Supplement 3 · standardAP
2020-05-05Labeling · Supplement 4 · standardAP
2020-05-05Labeling · Supplement 2 · standardAP
1996-03-25Labeling · Supplement 1AP
1989-02-16OriginalAP
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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