Application 203655

Type
ANDA
Sponsor
DR REDDYS LABS 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
43598-027Melphalan HydrochlorideMelphalan HydrochlorideDr.Reddy's Laboratories IncANDACurrent
43598-392Melphalan HydrochlorideMelphalan HydrochlorideDr.Reddy's Laboratories IncANDACurrent
43598-392Melphalan HydrochlorideMelphalan HydrochlorideDr.Reddy's Laboratories IncANDACurrent
43598-392Melphalan HydrochlorideMelphalan HydrochlorideDr.Reddy's Laboratories IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50936ORIG2017-12-28
50728ORIG2017-12-18