← FDA DRUG APPROVALS

FDA ANDA · ANDA062475

DOXY 100

doxycycline

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA062475
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-09
LATEST ACTION
2025-03-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOXY 100Prescription
DOXYCYCLINE HYCLATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
DOXY 200Prescription
DOXYCYCLINE HYCLATE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-03-31Labeling · Supplement 61 · standardAP
2020-04-22Labeling · Supplement 49 · standardAP
2020-04-22Labeling · Supplement 50 · standardAP
2016-01-26Labeling · Supplement 45 · standardAP
2016-01-26Labeling · Supplement 46 · standardAP
2016-01-26Labeling · Supplement 40 · standardAP
2014-01-28Labeling · Supplement 38 · standard — Label ↗AP
2008-02-27Labeling · Supplement 32AP
2005-10-17Labeling · Supplement 22AP
2003-04-02Labeling · Supplement 19AP
2003-04-02Labeling · Supplement 16AP
2002-12-05Manufacturing (CMC) · Supplement 17AP
1996-05-08Manufacturing (CMC) · Supplement 12AP
1994-11-08Manufacturing (CMC) · Supplement 10AP
1992-09-03Labeling · Supplement 11AP
1988-11-03Manufacturing (CMC) · Supplement 9AP
1983-12-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →