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OraDisc A Approval History

  • FDA approved: Yes (First approved September 29th, 2004)
  • Brand name: OraDisc A
  • Generic name: amlexanox
  • Dosage form: Mucoadhesive Patch
  • Company: Access Pharmaceuticals, Inc.
  • Treatment for: Aphthous Ulcer

OraDisc A is a mucoadhesive patch which gradually erodes and releases the active drug amlexanox when applied to the inside of the mouth. OraDisc A is approved for the treatment of aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

Development History and FDA Approval Process for OraDisc A

Sep 29, 2004Approval OraDisc A Access Pharmaceuticals, Inc. - Treatment for Aphthous Ulcers
Feb 19, 2004Access’ OraDisc A NDA Accepted For Filing

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