Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 202900

Expand all

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: A202900
Product Number: 001
Approval Date: Apr 30, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
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: A202900
Product Number: 002
Approval Date: Apr 30, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
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: A202900
Product Number: 003
Approval Date: Apr 30, 2018
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English