FDA.reportPublic FDA data

Application 050444

Type
NDA
Sponsor
REMPEX PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOCINMINOCYCLINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 100MG BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54531-100Minocinminocycline hydrochlorideRempex Pharmaceuticals, IncNDACurrent
65293-014Minocinminocycline hydrochlorideThe Medicines CompanyNDACurrent
65293-014Minocinminocycline hydrochlorideThe Medicines CompanyNDACurrent
65293-014Minocinminocycline hydrochlorideThe Medicines CompanyNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, IncNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, IncNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, IncNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, LLCNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, LLCNDACurrent
70842-160Minocinminocycline hydrochlorideMelinta Therapeutics, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81849SUPPL 2025-04-08
81784SUPPL 2025-03-31
17834SUPPL2015-04-22
17833SUPPL2014-11-18
30028SUPPL2014-10-27
38941SUPPL2010-09-20
7753SUPPL2010-09-17
17832SUPPL2007-01-18
7752SUPPL2007-01-18
7751SUPPL2005-10-20
38940SUPPL2005-09-30
7749SUPPL2005-02-17
42642SUPPL2004-06-29
30027SUPPL2004-06-01
7750SUPPL2004-06-01
7748SUPPL2002-05-31
30026SUPPL2002-01-30
30025SUPPL2002-01-30
7747SUPPL2002-01-30