FDA.reportPublic FDA data

Application 209826

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MELPHALAN HYDROCHLORIDEMELPHALAN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 50MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-259Melphalan hydrochlorideMelphalan hydrochlorideGland Pharma LimitedANDACurrent
70860-214Melphalan Hydrochloridemelphalan hydrochlorideAthenex Pharmaceutical Division, LLC.ANDACurrent
71288-112Melphalan hydrochlorideMelphalan hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
71288-112Melphalan hydrochlorideMelphalan hydrochlorideMeitheal Pharmaceuticals Inc.ANDACurrent
72266-128Melphalan hydrochlorideMelphalan hydrochlorideFosun Pharma USA IncANDACurrent
72266-128Melphalan hydrochlorideMelphalan hydrochlorideFosun Pharma USA IncANDACurrent