← FDA DRUG APPROVALS

FDA NDA · NDA050808

SOLODYN

Sponsor: BAUSCH

APPLICATION
NDA050808
TYPE
NDA
ORIGINAL APPROVAL
2006-05-08
LATEST ACTION
2025-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 80MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 115MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 135MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 55MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 105MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 65MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SOLODYN · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 90MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-04-01Labeling · Supplement 28 · standard — Label ↗AP
2025-03-18Labeling · Supplement 24 · standard — Letter ↗AP
2025-03-18Labeling · Supplement 27 · standard — Letter ↗AP
2016-02-03Manufacturing (CMC) · Supplement 18 · standardAP
2014-07-15Manufacturing (CMC) · Supplement 21 · standardAP
2013-10-21Labeling · Supplement 23 · standard — Label ↗AP
2013-04-17Manufacturing (CMC) · Supplement 20 · standardAP
2011-04-20Labeling · Supplement 15 · standard — Letter ↗AP
2011-03-18Labeling · Supplement 14 · unknown — Letter ↗AP
2010-08-07Labeling · Supplement 13 · standard — Label ↗AP
2009-12-30Labeling · Supplement 11 · standard — Label ↗AP
2009-07-23Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2007-02-27Manufacturing (CMC) · Supplement 3AP
2006-05-08Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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