Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 065488

Expand all

AZITHROMYCIN (AZITHROMYCIN)
EQ 100MG BASE/5ML Marketing Status: Prescription

Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 100MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065488
Product Number: 001
Approval Date: May 15, 2015
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

AZITHROMYCIN (AZITHROMYCIN)
EQ 200MG BASE/5ML Marketing Status: Prescription

Active Ingredient: AZITHROMYCIN
Proprietary Name: AZITHROMYCIN
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 200MG BASE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A065488
Product Number: 002
Approval Date: May 15, 2015
Applicant Holder Full Name: LUPIN 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