FDA.reportPublic FDA data

Application 210179

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARMUSTINECARMUSTINEINJECTABLE;INJECTION100MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68475-503CarmustinecarmustineNavinta LLCANDACurrent
68475-503CarmustinecarmustineNavinta LLCANDACurrent
68475-503CarmustinecarmustineNavinta LLCANDACurrent
68475-503CarmustinecarmustineNavinta LLCANDACurrent
68475-503CarmustinecarmustineNavinta LLCANDACurrent
70710-1525carmustinecarmustineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1525carmustinecarmustineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1525carmustinecarmustineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1525carmustinecarmustineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1525carmustinecarmustineZydus Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55950ORIG2018-10-15