Original New Drug Application Approvals by US FDA (01 - 15 March 2022)
16 Mar 2022
New drug applications approved by US FDA as of 01-15 March 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
- Active Ingredient(s): Donepezil Hydrochloride
- Strength: 5MG/24HR; 10MG/24HR
- Dosage Form(s) / Route(s): System; Transdermal
- Company: Corium, Inc.
- Approval Date: 11 March 2022
- Submission Classification: Type 3 - New Dosage Form
- Indication(s): Indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.
- Approved Label: 11 March 2022 (PDF)