FDA
Gabapentin Encarbil
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- GABAPENTIN ENCARBIL 300MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GABAPENTIN ENCARBIL 600MG · Tablet, extended releaseANDA213501-002 · Tentative approval
- GABAPENTIN ENCARBIL 300MG · Tablet, extended releaseThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA213501.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Gabapentin Encarbil
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Glenmark Pharms LTD
- Status
- Tentative approval
- FDA approval
- 29 Dec 2020
- Application
- ANDA213501-001