← FDA DRUG APPROVALS

FDA ANDA · ANDA090431

DOXYCYCLINE HYCLATE

Sponsor: RISING

APPLICATION
ANDA090431
TYPE
ANDA
ORIGINAL APPROVAL
2010-12-28
LATEST ACTION
2026-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 200MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 75MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 80MG BASE · TABLET, DELAYED RELEASE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET, DELAYED RELEASE · ORAL

Approval history

2026-04-09Labeling · Supplement 13 · standardAP
2026-04-09Labeling · Supplement 24 · standardAP
2026-04-09Labeling · Supplement 14 · standardAP
2026-04-09Labeling · Supplement 20 · standardAP
2016-05-23Manufacturing (CMC) · Supplement 10 — Letter ↗AP
2016-05-19Manufacturing (CMC) · Supplement 4 — Letter ↗AP
2016-04-29Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2015-12-11Labeling · Supplement 9 · standardAP
2015-09-16Labeling · Supplement 8 · standardAP
2015-01-16Labeling · Supplement 6 · standardAP
2011-12-15Labeling · Supplement 2AP
2010-12-28OriginalAP
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 →