Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 215654

Expand all

DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
EQ 4MG PHOSPHATE/ML
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Proprietary Name: DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4MG PHOSPHATE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215654
Product Number: 001
Approval Date: Aug 4, 2021
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE)
EQ 10MG PHOSPHATE/ML
Marketing Status: Prescription

Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Proprietary Name: DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG PHOSPHATE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215654
Product Number: 002
Approval Date: Sep 25, 2023
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information