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, 2004||OraDisc A Access Pharmaceuticals, Inc. - Treatment for Aphthous Ulcers|
|Feb 19, 2004||Access’ OraDisc A NDA Accepted For Filing|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.