Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022106

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DORIBAX (DORIPENEM)
250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: DORIPENEM
Proprietary Name: DORIBAX
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022106
Product Number: 002
Approval Date: Oct 5, 2010
Applicant Holder Full Name: SHIONOGI INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

DORIBAX (DORIPENEM)
500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: DORIPENEM
Proprietary Name: DORIBAX
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022106
Product Number: 001
Approval Date: Oct 12, 2007
Applicant Holder Full Name: SHIONOGI INC
Marketing Status:  Discontinued
Patent and Exclusivity Information