General MedicationsDENTALGeneric
APHTHASOL
AMLEXANOX
Standard Dose
5%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview APHTHASOL is listed in Drugs@FDA under application 020511 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient AMLEXANOX Form and strength PASTE;DENTAL - 5% Sponsor ULURU Submission history Latest submission status date: 2002-06-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview APHTHASOL is listed in Drugs@FDA under application 020511 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient AMLEXANOX Form and strength PASTE;DENTAL - 5% Sponsor ULURU Submission history Latest submission status date: 2002-06-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.