← FDA Drug Approvals (Drugs@FDA)
TROKENDI XR
NDA · New Drug Application · Sponsor: SUPERNUS PHARMS · Approved 2013-08-16
Drug application
- FDA Application #
NDA201635
- Application type
- New Drug Application
- Brand name
- TROKENDI XR
- Generic name
- TOPIRAMATE
- Active ingredients
- TOPIRAMATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SUPERNUS PHARMS
- Manufacturer
- Supernus Pharmaceuticals, Inc.
- First approval
- 2013-08-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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