Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 201107

ABACAVIR SULFATE (ABACAVIR SULFATE)
EQ 20MG BASE/ML Marketing Status: Prescription

Active Ingredient: ABACAVIR SULFATE
Proprietary Name: ABACAVIR SULFATE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 20MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A201107
Product Number: 001
Approval Date: Sep 26, 2016
Applicant Holder Full Name: HETERO LABS LTD UNIT III
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