Application 050808

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 45MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 90MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 135MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 65MG BASE	Yes	No
005	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 115MG BASE	Yes	Yes
006	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 105MG BASE	Yes	No
007	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 80MG BASE	Yes	No
008	SOLODYN	MINOCYCLINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 55MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-9935	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9935	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9935	minocycline hydrochloride	minocycline hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-9935	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9936	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9936	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9936	minocycline hydrochloride	minocycline hydrochloride	Amneal Pharmaceuticals of New York, LLC	NDA AUTHORIZED GENERIC	Current
0115-9936	minocycline hydrochloride	minocycline hydrochloride	Impax Generics	NDA AUTHORIZED GENERIC	Current
68682-466	minocycline hydrochloride	minocycline hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-467	minocycline hydrochloride	minocycline hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-468	minocycline hydrochloride	minocycline hydrochloride	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
99207-463	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-463	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-463	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-463	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-464	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-464	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-464	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-464	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-465	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-465	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-465	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-465	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-466	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-466	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-466	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-466	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-467	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current
99207-467	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-467	Solodyn	minocycline hydrochloride	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-467	Solodyn	minocycline hydrochloride	Bausch Health US LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81868	SUPPL	2025-04-08
81812	SUPPL	2025-04-02
81660	SUPPL	2025-03-20
81659	SUPPL	2025-03-20
81639	SUPPL	2025-03-19
81638	SUPPL	2025-03-19
30598	SUPPL	2013-10-22
39375	SUPPL	2013-10-21
22246	SUPPL	2012-03-27
30597	SUPPL	2011-04-21
8329	SUPPL	2011-03-25
18292	SUPPL	2011-03-18
39374	SUPPL	2010-12-16
18291	SUPPL	2010-01-12
30596	SUPPL	2010-01-05
8328	SUPPL	2009-07-31
18290	SUPPL	2009-07-30
22245	ORIG	2007-06-29
39373	ORIG	2006-05-16
30595	ORIG	2006-05-16

Application 050808

Related Records#

Application Products#

NDC Listings For This Application#

Documents#