Product Details for ANDA 211412
CELECOXIB (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: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211412
Product Number: 001
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
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: AB
Application Number: A211412
Product Number: 001
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211412
Product Number: 002
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
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: AB
Application Number: A211412
Product Number: 002
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211412
Product Number: 003
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
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: AB
Application Number: A211412
Product Number: 003
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
Patent and Exclusivity Information
400MG
Marketing Status: Prescription
Active Ingredient: CELECOXIB
Proprietary Name: CELECOXIB
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211412
Product Number: 004
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
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: AB
Application Number: A211412
Product Number: 004
Approval Date: Mar 6, 2020
Applicant Holder Full Name: YILING PHARMACEUTICAL LTD
Marketing Status: Prescription
Patent and Exclusivity Information