Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217695

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DEXAMETHASONE (DEXAMETHASONE)
0.5MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 001
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
0.75MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 002
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
1MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 003
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
1.5MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 004
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
2MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 005
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
4MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 006
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE (DEXAMETHASONE)
6MG
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE
Proprietary Name: DEXAMETHASONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A217695
Product Number: 007
Approval Date: Aug 23, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information