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Aurobindo Receives FDA Approval for Hydrocortisone Tablets USP, 5 mg, 10 mg, and 20 mg

Published: July 17, 2023

East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Hydrocortisone Tablets USP, 5 mg, 10 mg, and 20 mg. Aurobindo Pharma’s Hydrocortisone Tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), CORTEF® tablets manufactured by Pharmacia and Upjohn Co.

Hydrocortisone Tablets are indicated in the following conditions:

  • Endocrine Disorders
  • Rheumatic Disorders
  • Collagen Diseases
  • Dermatologic Diseases
  • Allergic States
  • Ophthalmic Diseases
  • Respiratory Diseases
  • Hematologic Disorders
  • Neoplastic Diseases
  • Edematous States
  • Gastrointestinal Diseases.