Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016269

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MANNITOL 25% (MANNITOL)
12.5GM/50ML
Marketing Status: Prescription

Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 25%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 12.5GM/50ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N016269
Product Number: 006
Approval Date: Aug 25, 1994
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MANNITOL 10% (MANNITOL)
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: N016269
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MANNITOL 15% (MANNITOL)
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: N016269
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MANNITOL 20% (MANNITOL)
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: N016269
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MANNITOL 25% (MANNITOL)
12.5GM/50ML
Marketing Status: Discontinued

Active Ingredient: MANNITOL
Proprietary Name: MANNITOL 25%
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 12.5GM/50ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N016269
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

MANNITOL 5% (MANNITOL)
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: N016269
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HOSPIRA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information