← FDA DRUG APPROVALS

FDA NDA · NDA050795

DOXYCYCLINE HYCLATE

Sponsor: MAYNE PHARMA

APPLICATION
NDA050795
TYPE
NDA
ORIGINAL APPROVAL
2005-05-06
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued, Prescription

Products

DORYX MPC · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 80MG BASE · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
DORYX MPC · ReferencePrescription
DOXYCYCLINE HYCLATE EQ 60MG BASE · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 200MG BASE · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL
DORYX · ReferenceDiscontinued
DOXYCYCLINE HYCLATE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2025-03-31Labeling · Supplement 37 · standard — Label ↗AP
2024-07-15Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2022-07-25Labeling · Supplement 30 · standard — Letter ↗AP
2020-02-12Labeling · Supplement 28 · standard — Label ↗AP
2018-02-07Labeling · Supplement 26 · standard — Label ↗AP
2017-05-31Efficacy · Supplement 24 · standard — Label ↗AP
2016-05-20Efficacy · Supplement 22 · standard — Label ↗AP
2016-05-18Labeling · Supplement 21 · standard — Label ↗AP
2015-06-04Labeling · Supplement 18 · standard — Label ↗AP
2015-03-04Labeling · Supplement 20 · standard — Label ↗AP
2014-12-19Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2013-12-06Manufacturing (CMC) · Supplement 16 · standardAP
2013-12-06Manufacturing (CMC) · Supplement 17 · standardAP
2013-11-25Manufacturing (CMC) · Supplement 15 · standardAP
2013-04-11Efficacy · Supplement 10 · priority — Pediatric Clinical Pharmacology Review ↗AP
2013-04-11Manufacturing (CMC) · Supplement 11 · standardAP
2011-09-13Manufacturing (CMC) · Supplement 14 · standard — Label ↗AP
2011-03-21Labeling · Supplement 13 · standard — Letter ↗AP
2008-06-20Manufacturing (CMC) · Supplement 5 — Label ↗AP
2007-12-18Labeling · Supplement 3 · standard — Label ↗AP
2006-12-19Efficacy · Supplement 2 · unknown — Label ↗AP
2005-05-06Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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