Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209916

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BUMETANIDE (BUMETANIDE)
0.5MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMETANIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209916
Product Number: 001
Approval Date: Jan 23, 2018
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUMETANIDE (BUMETANIDE)
1MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMETANIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209916
Product Number: 002
Approval Date: Jan 23, 2018
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

BUMETANIDE (BUMETANIDE)
2MG
Marketing Status: Prescription

Active Ingredient: BUMETANIDE
Proprietary Name: BUMETANIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209916
Product Number: 003
Approval Date: Jan 23, 2018
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information