Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018225

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BUMEX (BUMETANIDE)
0.5MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018225
Product Number: 002
Approval Date: Feb 28, 1983
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUMEX (BUMETANIDE)
1MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018225
Product Number: 001
Approval Date: Feb 28, 1983
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUMEX (BUMETANIDE)
2MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N018225
Product Number: 003
Approval Date: Jun 14, 1985
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information