Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 202691

Expand all

METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
EQ 500MG BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 500MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202691
Product Number: 001
Approval Date: Feb 16, 2016
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE SODIUM SUCCINATE)
EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Proprietary Name: METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1GM BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202691
Product Number: 002
Approval Date: Feb 16, 2016
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
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