Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 201277

Expand all

GADAVIST (GADOBUTROL)
1.20944GM/2ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.20944GM/2ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 006
Approval Date: Dec 18, 2013
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GADAVIST (GADOBUTROL)
4.5354GM/7.5ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4.5354GM/7.5ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 001
Approval Date: Mar 14, 2011
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GADAVIST (GADOBUTROL)
6.0472GM/10ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 6.0472GM/10ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 002
Approval Date: Mar 14, 2011
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GADAVIST (GADOBUTROL)
9.0708GM/15ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 9.0708GM/15ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 003
Approval Date: Mar 14, 2011
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GADAVIST (GADOBUTROL)
18.1416GM/30ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 18.1416GM/30ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 004
Approval Date: Mar 14, 2011
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

GADAVIST (GADOBUTROL)
39.3068GM/65ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADAVIST
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 39.3068GM/65ML (604.72MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N201277
Product Number: 005
Approval Date: Mar 14, 2011
Applicant Holder Full Name: BAYER HEALTHCARE PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information