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OraDisc A FDA Approval History

FDA Approved: Yes (First approved September 29, 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 timeline for OraDisc A

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

Further information

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