Product Details for NDA 014694
HEXADROL (DEXAMETHASONE SODIUM PHOSPHATE)
EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 20MG PHOSPHATE/ML
Marketing Status: Discontinued
EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEXADROL (DEXAMETHASONE SODIUM PHOSPHATE)
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
HEXADROL (DEXAMETHASONE SODIUM PHOSPHATE)
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 20MG PHOSPHATE/ML
Marketing Status: Discontinued
Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG PHOSPHATE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HEXADROL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 20MG PHOSPHATE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N014694
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ASPEN GLOBAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information