FDA
Safinamide Mesylate
The FDA lists this product in 8 strengths and forms.
Composition
- Active ingredients
- SAFINAMIDE MESYLATE EQ 100MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- SAFINAMIDE MESYLATE EQ 100MG BASE · TabletANDA215913-002 · Prescription
- SAFINAMIDE MESYLATE EQ 50MG BASE · TabletANDA215913-001 · Prescription
- SAFINAMIDE MESYLATE EQ 50MG BASE · TabletANDA215978-001 · Prescription
- SAFINAMIDE MESYLATE EQ 100MG BASE · TabletThis page
- SAFINAMIDE MESYLATE EQ 100MG BASE · TabletANDA215902-002 · Discontinued
- SAFINAMIDE MESYLATE EQ 50MG BASE · TabletANDA215902-001 · Discontinued
- SAFINAMIDE MESYLATE EQ 50MG BASE · TabletANDA215739-001 · Prescription
- SAFINAMIDE MESYLATE EQ 100MG BASE · TabletANDA215739-002 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA215978.
At a glance
- Brand name
- Safinamide Mesylate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- MSN
- Status
- Prescription
- FDA approval
- 31 Dec 2024
- Application
- ANDA215978-002