Product Details for NDA 016080
MANNITOL 10% (MANNITOL)
10GM/100ML
Marketing Status: Discontinued
10GM/100ML
Marketing Status: Discontinued
15GM/100ML
Marketing Status: Discontinued
15GM/100ML
Marketing Status: Discontinued
20GM/100ML
Marketing Status: Discontinued
5GM/100ML
Marketing Status: Discontinued
5GM/100ML
Marketing Status: Discontinued
10GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 10%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER (MANNITOL)
Proprietary Name: MANNITOL 10%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
10GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 15% (MANNITOL)
Proprietary Name: MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 10GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 15%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% (MANNITOL)
Proprietary Name: MANNITOL 15%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
15GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 20% (MANNITOL)
Proprietary Name: MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 20%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 5% (MANNITOL)
Proprietary Name: MANNITOL 20%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 20GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% (MANNITOL)
Proprietary Name: MANNITOL 5%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
5GM/100ML
Marketing Status: Discontinued
Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5GM/100ML
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016080
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: B BRAUN MEDICAL INC
Marketing Status: Discontinued
Patent and Exclusivity Information