FDA.reportPublic FDA data

Application 078857

Type
ANDA
Sponsor
MYLAN

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
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7150CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7160CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7165CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
0378-7170CelecoxibcelecoxibMylan Pharmaceuticals Inc.ANDACurrent
43353-257CelecoxibcelecoxibAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-199CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
51079-199CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
51079-199CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
51079-215CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
51079-215CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
51079-215CelecoxibcelecoxibMylan Institutional Inc.ANDACurrent
60429-459CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-459CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-459CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-460CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-460CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-460CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-460CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-460CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-461CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-461CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-461CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-461CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-461CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-462CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-462CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
60429-462CelecoxibcelecoxibGolden State Medical Supply, Inc.ANDACurrent
71335-0437CelecoxibcelecoxibBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31392ORIG2014-06-02