FDA.reportPublic FDA data

Application 050649

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 50MG BASEYesNo
002MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 100MG BASEYesNo
003MINOCINMINOCYCLINE HYDROCHLORIDECAPSULE;ORALEQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-400Minocinminocycline hydrochlorideOnset Dermatologics LLCNDACurrent
16781-400Minocinminocycline hydrochlorideBausch Health US, LLCNDACurrent
16781-403Minocinminocycline hydrochlorideOnset Dermatologics LLCNDACurrent
16781-403Minocinminocycline hydrochlorideBausch Health US, LLCNDACurrent
43353-172Minocinminocycline hydrochlorideAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81853SUPPL 2025-04-08
81793SUPPL 2025-04-02
79144SUPPL 2024-07-22
79129SUPPL 2024-07-22
49037SUPPL2017-07-21
49025SUPPL2017-07-20
46175SUPPL2016-12-15
46189SUPPL2016-12-14
39073SUPPL2015-03-26
30224SUPPL2015-03-11
17973SUPPL2010-09-20
30223SUPPL2010-09-17
7935SUPPL2008-07-01
39072SUPPL2008-06-30
30222SUPPL2007-06-04
7933SUPPL2007-04-09
17972SUPPL2007-04-06
7934SUPPL2007-02-02
39071SUPPL2007-01-25
7932SUPPL2005-10-20
30220SUPPL2005-02-17
42664SUPPL2004-06-29
30221SUPPL2004-06-01
7931SUPPL2004-06-01
7930SUPPL2002-05-31
7929SUPPL2002-02-01
7928SUPPL2002-02-01