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