FDA.reportPublic FDA data

Application 202240

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELECOXIBCELECOXIBCAPSULE;ORAL50MGNoNo
002CELECOXIBCELECOXIBCAPSULE;ORAL100MGNoNo
003CELECOXIBCELECOXIBCAPSULE;ORAL200MGNoNo
004CELECOXIBCELECOXIBCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8297celecoxibcelecoxibNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8297celecoxibcelecoxibNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8338celecoxibcelecoxibNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50090-5638celecoxibcelecoxibA-S Medication SolutionsANDACurrent
68180-395celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-395celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-395celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-395celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-395celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-396celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-396celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-396celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-396celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-396celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-397celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-397celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-397celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-397celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-398celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-398celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-398celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-398celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-398celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-399celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-399celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent
68180-399celecoxibcelecoxibLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19299ORIG2015-06-19
9995ORIG2015-06-11
32213ORIG2015-04-10