APPLICATION
ANDA062450
TYPE
ANDA
ORIGINAL APPROVAL
1983-10-27
LATEST ACTION
2025-04-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOXYCYCLINEDiscontinued
DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
DOXYCYCLINEDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-04-08Labeling · Supplement 23 · standardAP
2020-05-01Labeling · Supplement 21 · standardAP
2020-05-01Labeling · Supplement 22 · standardAP
1995-09-18Manufacturing (CMC) · Supplement 20AP
1994-08-18Manufacturing (CMC) · Supplement 17AP
1994-03-23Manufacturing (CMC) · Supplement 18AP
1993-10-22Manufacturing (CMC) · Supplement 15AP
1993-10-22Manufacturing (CMC) · Supplement 16AP
1993-09-29Labeling · Supplement 14AP
1992-04-28Manufacturing (CMC) · Supplement 13AP
1991-11-20Manufacturing (CMC) · Supplement 12AP
1990-02-26Manufacturing (CMC) · Supplement 11AP
1988-10-03Manufacturing (CMC) · Supplement 10AP
1983-10-27OriginalAP
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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