Application 077130

Type
ANDA
Sponsor
DR REDDYS LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 1.5MG BASENoYes
002RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 3MG BASENoNo
003RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 4.5MG BASENoNo
004RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATECAPSULE;ORALEQ 6MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55111-352Rivastigmine TartrateRivastigmine TartrateDr. Reddy's Laboratories LimitedANDACurrent
55111-353Rivastigmine TartrateRivastigmine TartrateDr. Reddy's Laboratories LimitedANDACurrent
55111-354Rivastigmine TartrateRivastigmine TartrateDr. Reddy's Laboratories LimitedANDACurrent
55111-355Rivastigmine TartrateRivastigmine TartrateDr. Reddy's Laboratories LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31199ORIG2007-11-08