Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 205962

BIVALIRUDIN (BIVALIRUDIN)
250MG/VIAL
Marketing Status: Prescription
Active Ingredient: BIVALIRUDIN
Proprietary Name: BIVALIRUDIN
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: 250MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A205962
Product Number: 001
Approval Date: Jul 27, 2018
Applicant Holder Full Name: AUROBINDO PHARMA LTD
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