Application 077461

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATEGLINIDENATEGLINIDETABLET;ORAL60MGNoNo
002NATEGLINIDENATEGLINIDETABLET;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55111-328NateglinideNateglinideDr. Reddy's Laboratories LimitedANDACurrent
55111-328NateglinideNateglinideDr. Reddy's Laboratories LimitedANDACurrent
55111-329NateglinideNateglinideDr. Reddy's Laboratories LimitedANDACurrent
55111-329NateglinideNateglinideDr. Reddy's Laboratories LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9047ORIG2009-09-16