← FDA DRUG APPROVALS

FDA ANDA · ANDA062581

DOXY-LEMMON

Sponsor: TEVA

APPLICATION
ANDA062581
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-15
LATEST ACTION
2014-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DOXY-LEMMONDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · TABLET · ORAL

Approval history

2014-05-19Labeling · Supplement 22 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 21AP
1995-03-02Manufacturing (CMC) · Supplement 20AP
1994-01-26Manufacturing (CMC) · Supplement 18AP
1994-01-26Manufacturing (CMC) · Supplement 16AP
1994-01-26Manufacturing (CMC) · Supplement 14AP
1994-01-26Manufacturing (CMC) · Supplement 19AP
1994-01-26Manufacturing (CMC) · Supplement 17AP
1994-01-26Manufacturing (CMC) · Supplement 15AP
1993-08-31Manufacturing (CMC) · Supplement 12AP
1993-08-31Manufacturing (CMC) · Supplement 13AP
1993-04-01Manufacturing (CMC) · Supplement 10AP
1993-04-01Manufacturing (CMC) · Supplement 11AP
1992-10-21Manufacturing (CMC) · Supplement 9AP
1989-03-22Manufacturing (CMC) · Supplement 8AP
1985-03-15OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →