Composition
- Active ingredients
- HYDRALAZINE HYDROCHLORIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- HYDRALAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA008303-001 · Discontinued
- HYDRALAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA008303-004 · Discontinued
- HYDRALAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA008303-002 · Discontinued
- HYDRALAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA008303-005 · Discontinued
- HYDRALAZINE HYDROCHLORIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA008303.
At a glance
- Brand name
- Apresoline
- Active substance
- hydralazine hydrochloride
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Novartis
- Status
- Discontinued
- FDA approval
- 15 Jan 1953
- Application
- NDA008303-003