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FDA ANDA · ANDA065055

DOXYCYCLINE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA065055
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-01
LATEST ACTION
2026-03-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

DOXYCYCLINEPrescription
DOXYCYCLINE EQ 50MG BASE · CAPSULE · ORAL
DOXYCYCLINEDiscontinued
DOXYCYCLINE EQ 75MG BASE · CAPSULE · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 100MG BASE · CAPSULE · ORAL
DOXYCYCLINEPrescription
DOXYCYCLINE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2026-03-11Labeling · Supplement 30 · standardAP
2024-08-26Labeling · Supplement 22 · standardAP
2024-08-26Labeling · Supplement 27 · standardAP
2024-08-26Labeling · Supplement 19 · standardAP
2024-08-26Labeling · Supplement 21 · standardAP
2016-09-23Labeling · Supplement 16 · standardAP
2014-09-26Labeling · Supplement 15 · standardAP
2014-07-10Labeling · Supplement 13 · standardLabelAP
2012-12-14Labeling · Supplement 12 · standardLabelAP
2012-04-18Labeling · Supplement 11AP
2009-03-12Labeling · Supplement 10AP
2005-08-01Labeling · Supplement 5AP
2005-07-15Supplement · Supplement 6AP
2005-04-18Supplement · Supplement 3AP
2005-04-18Labeling · Supplement 4AP
2005-04-15Labeling · Supplement 7AP
2004-02-20Labeling · Supplement 2AP
2002-12-19Labeling · Supplement 1AP
2000-12-01OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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