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MINOCIN

NDA

MINOCYCLINE HYDROCHLORIDE | N050649 | BAUSCH HEALTH US LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain9 active DMFs7 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -29	View Letter (PDF)
Jul 22, 2024	SUPPL -28	View Letter (PDF)
Jul 21, 2017	SUPPL -27	View Letter (PDF)
Dec 15, 2016	SUPPL -26	View Letter (PDF)
Mar 11, 2015	SUPPL -25	View Letter (PDF)
Sep 17, 2010	SUPPL -23	View Letter (PDF)
Jul 1, 2008	SUPPL -22	View Letter (PDF)
Jun 4, 2007	SUPPL -21	View Letter (PDF)
Apr 9, 2007	SUPPL -19	View Letter (PDF)
Feb 2, 2007	SUPPL -20	View Letter (PDF)
Oct 20, 2005	SUPPL -18	View Letter (PDF)
Feb 17, 2005	SUPPL -15	View Letter (PDF)
Jun 1, 2004	SUPPL -17	View Letter (PDF)
Jun 1, 2004	SUPPL -16	View Letter (PDF)
May 31, 2002	SUPPL -11	View Letter (PDF)
Feb 1, 2002	SUPPL -5	View Letter (PDF)
Feb 1, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 31, 1990

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 31, 1990

#003 — EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 12, 2001