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FDA NDA · NDA205931

DOXYCYCLINE HYCLATE

Sponsor: CHARTWELL RX

APPLICATION
NDA205931
TYPE
NDA
ORIGINAL APPROVAL
2014-07-25
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ACTICLATE · ReferencePrescription
DOXYCYCLINE HYCLATE EQ 150MG BASE · TABLET · ORAL
ACTICLATE · ReferencePrescription
DOXYCYCLINE HYCLATE EQ 75MG BASE · TABLET · ORAL

Approval history

2025-03-31Labeling · Supplement 6 · standard — Label ↗AP
2020-03-04Labeling · Supplement 5 · standard — Letter ↗AP
2019-12-26Labeling · Supplement 4 · standard — Letter ↗AP
2017-11-15Labeling · Supplement 3 · standard — Letter ↗AP
2016-04-26Labeling · Supplement 2 · standard — Label ↗AP
2014-07-25Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
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.

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