FDA.reportPublic FDA data

Application 078179

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL12.5MGNoNo
002ZOLPIDEM TARTRATEZOLPIDEM TARTRATETABLET, EXTENDED RELEASE;ORAL6.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-3481Zolpidem TartrateZolpidem TartrateActavis Pharma, Inc.ANDACurrent
0228-3481Zolpidem TartrateZolpidem TartrateActavis Pharma, Inc.ANDACurrent
0228-3482Zolpidem TartrateZolpidem TartrateActavis Pharma, Inc.ANDACurrent
0228-3482Zolpidem TartrateZolpidem TartrateActavis Pharma, Inc.ANDACurrent
0228-3482Zolpidem TartrateZolpidem TartrateActavis Pharma, Inc.ANDACurrent
35356-845Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-495Zolpidem TartrateZolpidem TartrateLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-449ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
61919-449ZOLPIDEM TARTRATEZOLPIDEM TARTRATEDIRECT RXANDACurrent
68084-523Zolpidem TartrateZolpidem TartrateAmerican Health PackagingANDACurrent
71335-0079Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0079Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0134Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0134Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent
71335-0134Zolpidem TartrateZolpidem TartrateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31340ORIG2010-10-20