Composition
- Active ingredients
- LABETALOL HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- LABETALOL HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableThis page
- LABETALOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA018687-001 · Discontinued
- LABETALOL HYDROCHLORIDE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA018687-004 · Discontinued
- LABETALOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA018687-002 · Discontinued
- LABETALOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA018687-003 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA018686.
At a glance
- Brand name
- Normodyne
- Active substance
- labetalol hydrochloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Schering
- Status
- Discontinued
- FDA approval
- 1 Aug 1984
- Application
- NDA018686-001