FDA
Rosiglitazone
The FDA lists this product in 6 strengths and forms.
Composition
- Active ingredients
- ROSIGLITAZONE MALEATE 4MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ROSIGLITAZONE MALEATE 4MG · TabletANDA076748-002 · Tentative approval
- ROSIGLITAZONE MALEATE 8MG · TabletANDA076748-003 · Tentative approval
- ROSIGLITAZONE MALEATE 2MG · TabletANDA076748-001 · Tentative approval
- ROSIGLITAZONE MALEATE 8MG · TabletANDA078023-003 · Tentative approval
- ROSIGLITAZONE MALEATE 2MG · TabletANDA078023-001 · Tentative approval
- ROSIGLITAZONE MALEATE 4MG · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA078023.
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
- Rosiglitazone
- Active substance
- rosiglitazone maleate
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Watson Labs
- Status
- Tentative approval
- FDA approval
- 31 Jan 2007
- Application
- ANDA078023-002