FDA.reportPublic FDA data

Application 077239

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZALEPLONZALEPLONCAPSULE;ORAL5MGNoNo
002ZALEPLONZALEPLONCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5268ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5268ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5269ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5269ZaleplonZaleplonTeva Pharmaceuticals USA, Inc.ANDACurrent
50090-3420ZaleplonZaleplonA-S Medication SolutionsANDACurrent
50436-1006ZaleplonZaleplonUnit Dose ServicesANDACurrent
55700-190ZaleplonZaleplonLake Erie Medical DBA Quality Care Products LLCANDACurrent
66336-056ZaleplonZaleplonDispensing Solutions, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18458ORIG2008-07-14
23864ORIG2008-07-01
31209ORIG2008-06-10