FDA NDA · NDA050781

ARESTIN

minocycline hydrochloride

Sponsor: ORAPHARMA

APPLICATION

NDA050781

TYPE

NDA

ORIGINAL APPROVAL

2001-02-16

LATEST ACTION

2024-05-24

ROUTE

ORAL, DENTAL

DOSAGE FORM

POWDER, EXTENDED RELEASE

MARKETING STATUS

Prescription

Products

ARESTIN · ReferencePrescription

MINOCYCLINE HYDROCHLORIDE EQ 1MG BASE · POWDER, EXTENDED RELEASE · DENTAL

2024-05-24Labeling · Supplement 25 · standard — Label ↗AP

2017-05-08Labeling · Supplement 20 · standard — Label ↗AP

2012-07-27Labeling · Supplement 19 · standard — Label ↗AP

2008-02-15Labeling · Supplement 12 · standard — Label ↗AP

2008-02-15Manufacturing (CMC) · Supplement 11AP

2002-01-28Manufacturing (CMC) · Supplement 6 · standardAP

2001-10-12Manufacturing (CMC) · Supplement 5 · standardAP

2001-09-14Manufacturing (CMC) · Supplement 4 · standardAP

2001-08-14Manufacturing (CMC) · Supplement 2 · standardAP

2001-08-14Manufacturing (CMC) · Supplement 3 · standardAP

2001-07-13Manufacturing (CMC) · Supplement 1 · standardAP

2001-02-16Type 3 - New Dosage Form · Original · standard — Label ↗AP

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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