Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020998

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CELEBREX (CELECOXIB)
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)
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)
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)
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