Composition
- Active ingredients
- METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- METFORMIN HYDROCHLORIDE 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020357-004 · Discontinued
- METFORMIN HYDROCHLORIDE 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020357-002 · Discontinued
- METFORMIN HYDROCHLORIDE 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020357-005 · Discontinued
- METFORMIN HYDROCHLORIDE 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA020357-003 · Discontinued
- METFORMIN HYDROCHLORIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA020357.
At a glance
- Brand name
- Glucophage
- Active substance
- metformin hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Emd Serono Inc
- Status
- Discontinued
- FDA approval
- 3 Mar 1995
- Application
- NDA020357-001