FDA.reportPublic FDA data

Application 077463

Type
ANDA
Sponsor
PAR PHARM

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
0615-7585NateglinideNateglinideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7586NateglinideNateglinideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42291-636NateglinideNateglinideAvKARE, Inc.ANDACurrent
42291-636NateglinideNateglinideAvKAREANDACurrent
42291-636NateglinideNateglinideAvKARE, Inc.ANDACurrent
42291-637NateglinideNateglinideAvKARE, Inc.ANDACurrent
42291-637NateglinideNateglinideAvKARE, Inc.ANDACurrent
42291-637NateglinideNateglinideAvKAREANDACurrent
49884-984NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-984NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-984NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-984NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-985NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-985NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-985NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
49884-985NateglinideNateglinidePar Pharmaceutical, Inc.ANDACurrent
51407-656NateglinidenateglinideGolden State Medical Supply, Inc.ANDACurrent
51407-657NateglinidenateglinideGolden State Medical Supply, Inc.ANDACurrent
60429-434NateglinideNateglinideGolden State Medical Supply, Inc.ANDACurrent
60429-434NateglinideNateglinideGolden State Medical Supply, Inc.ANDACurrent
60429-435NateglinideNateglinideGolden State Medical Supply, Inc.ANDACurrent
60429-435NateglinideNateglinideGolden State Medical Supply, Inc.ANDACurrent
60687-673NateglinidenateglinideAmerican Health PackagingANDACurrent
60687-673NateglinidenateglinideAmerican Health PackagingANDACurrent
60687-684NateglinidenateglinideAmerican Health PackagingANDACurrent
60687-684NateglinidenateglinideAmerican Health PackagingANDACurrent
64380-167NateglinidenateglinideStrides Pharma Science LimitedANDACurrent
64380-167NateglinidenateglinideStrides Pharma Science LimitedANDACurrent
64380-168NateglinidenateglinideStrides Pharma Science LimitedANDACurrent
64380-168NateglinidenateglinideStrides Pharma Science LimitedANDACurrent
68084-458NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-458NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-458NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-458NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-458NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-459NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-459NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-459NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-459NateglinideNateglinideAmerican Health PackagingANDACurrent
68084-459NateglinideNateglinideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39531ORIG2009-10-21
31243ORIG2009-09-16
31242ORIG2006-08-14