Composition
- Active ingredients
- GLIMEPIRIDE 4MG; ROSIGLITAZONE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GLIMEPIRIDE 2MG; ROSIGLITAZONE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021700-004 · Discontinued
- GLIMEPIRIDE 2MG; ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021700-002 · Discontinued
- GLIMEPIRIDE 4MG; ROSIGLITAZONE MALEATE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- GLIMEPIRIDE 4MG; ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021700-003 · Discontinued
- GLIMEPIRIDE 1MG; ROSIGLITAZONE MALEATE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA021700-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA021700.
At a glance
- Brand name
- Avandaryl
- Active substance
- glimepiride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- SB Pharmco
- Status
- Discontinued
- FDA approval
- 23 Nov 2005
- Application
- NDA021700-005