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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019887

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NEBUPENT (PENTAMIDINE ISETHIONATE)
300MG/VIAL
Marketing Status: Prescription
Active Ingredient: PENTAMIDINE ISETHIONATE
Proprietary Name: NEBUPENT
Dosage Form; Route of Administration: FOR SOLUTION; INHALATION
Strength: 300MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AN
Application Number: N019887
Product Number: 001
Approval Date: Jun 15, 1989
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
NEBUPENT (PENTAMIDINE ISETHIONATE)
600MG/VIAL
Marketing Status: Discontinued
Active Ingredient: PENTAMIDINE ISETHIONATE
Proprietary Name: NEBUPENT
Dosage Form; Route of Administration: FOR SOLUTION; INHALATION
Strength: 600MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N019887
Product Number: 002
Approval Date: Mar 22, 1996
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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