Product Details for ANDA 078857
CELECOXIB (CELECOXIB)
50MG
Marketing Status: Discontinued
100MG
Marketing Status: Discontinued
200MG
Marketing Status: Discontinued
400MG
Marketing Status: Discontinued
50MG
Marketing Status: Discontinued
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 001
Approval Date: May 30, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CELECOXIB (CELECOXIB)
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 001
Approval Date: May 30, 2014
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG
Marketing Status: Discontinued
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 002
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CELECOXIB (CELECOXIB)
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 002
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
200MG
Marketing Status: Discontinued
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 003
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
CELECOXIB (CELECOXIB)
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 003
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
400MG
Marketing Status: Discontinued
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 004
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078857
Product Number: 004
Approval Date: Feb 11, 2015
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information