Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022348

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CALDOLOR (IBUPROFEN)
800MG/8ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: IBUPROFEN
Proprietary Name: CALDOLOR
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 800MG/8ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022348
Product Number: 002
Approval Date: Jun 11, 2009
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CALDOLOR (IBUPROFEN)
800MG/200ML (4MG/ML)
Marketing Status: Prescription

Active Ingredient: IBUPROFEN
Proprietary Name: CALDOLOR
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 800MG/200ML (4MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022348
Product Number: 003
Approval Date: Jan 25, 2019
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CALDOLOR (IBUPROFEN)
400MG/4ML (100MG/ML)
Marketing Status: Discontinued

Active Ingredient: IBUPROFEN
Proprietary Name: CALDOLOR
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 400MG/4ML (100MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022348
Product Number: 001
Approval Date: Jun 11, 2009
Applicant Holder Full Name: CUMBERLAND PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information