← FDA DRUG APPROVALS

FDA ANDA · ANDA062418

DOXYCYCLINE HYCLATE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA062418
TYPE
ANDA
ORIGINAL APPROVAL
1983-01-28
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE · CAPSULE · ORAL
DOXYCYCLINE HYCLATEDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE · CAPSULE · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 28AP
1995-08-16Manufacturing (CMC) · Supplement 27AP
1995-01-10Manufacturing (CMC) · Supplement 14AP
1994-12-23Manufacturing (CMC) · Supplement 26AP
1994-10-11Manufacturing (CMC) · Supplement 25AP
1993-12-13Labeling · Supplement 24AP
1993-07-22Labeling · Supplement 23AP
1992-05-01Labeling · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1992-04-03Manufacturing (CMC) · Supplement 16AP
1992-02-11Labeling · Supplement 15AP
1983-01-28OriginalAP
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 →