← FDA DRUG APPROVALS

FDA NDA · NDA050641

DOXYCYCLINE MONOHYDRATE

Sponsor: CHARTWELL RX

APPLICATION
NDA050641
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MONODOX · ReferencePrescription
DOXYCYCLINE EQ 75MG BASE · CAPSULE · ORAL
MONODOX · ReferencePrescription
DOXYCYCLINE EQ 100MG BASE · CAPSULE · ORAL
MONODOX · ReferencePrescription
DOXYCYCLINE EQ 150MG BASE · CAPSULE · ORAL
MONODOX · ReferencePrescription
DOXYCYCLINE EQ 50MG BASE · CAPSULE · ORAL

Approval history

2025-03-31Labeling · Supplement 34 · standard — Label ↗AP
2024-05-08Labeling · Supplement 33 · standard — Letter ↗AP
2022-02-17Manufacturing (CMC) · Supplement 32 — Label ↗AP
2017-04-03Labeling · Supplement 29 · standard — Label ↗AP
2016-08-05Manufacturing (CMC) · Supplement 28 · standardAP
2013-10-11Labeling · Supplement 27 · standard — Letter ↗AP
2012-01-11Labeling · Supplement 18 · standard — Letter ↗AP
2011-03-08Labeling · Supplement 26 · standard — Letter ↗AP
2007-12-20Labeling · Supplement 14 · standard — Label ↗AP
2007-01-31Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2002-06-18Labeling · Supplement 10 · standard — Letter ↗AP
2002-03-21Labeling · Supplement 8 · standard — Letter ↗AP
1994-01-07Manufacturing (CMC) · Supplement 7 · standardAP
1992-06-24Manufacturing (CMC) · Supplement 6 · standardAP
1992-03-06Labeling · Supplement 5AP
1992-02-10Manufacturing (CMC) · Supplement 3 · standardAP
1991-11-15Labeling · Supplement 4AP
1991-11-15Labeling · Supplement 1AP
1991-09-25Manufacturing (CMC) · Supplement 2 · standardAP
1989-12-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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