Product Details for NDA 020998
CELEBREX (CELECOXIB)
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
400MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 004
Approval Date: Dec 15, 2006
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CELEBREX (CELECOXIB)
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 004
Approval Date: Dec 15, 2006
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 001
Approval Date: Dec 31, 1998
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CELEBREX (CELECOXIB)
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 001
Approval Date: Dec 31, 1998
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 002
Approval Date: Dec 31, 1998
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
CELEBREX (CELECOXIB)
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020998
Product Number: 002
Approval Date: Dec 31, 1998
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
400MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020998
Product Number: 003
Approval Date: Aug 29, 2002
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CELEBREX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020998
Product Number: 003
Approval Date: Aug 29, 2002
Applicant Holder Full Name: UPJOHN US 2 LLC
Marketing Status: Prescription
Patent and Exclusivity Information