FDA
Bupropion Hydrobromide
The FDA lists this product in 2 strengths and forms.
Composition
- Active ingredients
- BUPROPION HYDROBROMIDE 522MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BUPROPION HYDROBROMIDE 522MG · Tablet, extended releaseThis page
- BUPROPION HYDROBROMIDE 174MG · Tablet, extended releaseANDA200835-001 · Tentative approval
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA200835.
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
- Bupropion Hydrobromide
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Watson Labs Inc
- Status
- Tentative approval
- FDA approval
- 13 Aug 2013
- Application
- ANDA200835-002