FDA
Dolophine Hydrochloride
The FDA lists this product in 3 strengths and forms.
Composition
- Active ingredients
- METHADONE HYDROCHLORIDE 10MG/30ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- METHADONE HYDROCHLORIDE 10MG/30ML · SyrupThis page
- METHADONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA006134-010 · Discontinued
- METHADONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA006134-002 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA006134.
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
- Dolophine Hydrochloride
- Active substance
- methadone hydrochloride
- Route
- Oral
- Dosage form
- Syrup
- Applicant
- Hikma
- Status
- Discontinued
- FDA approval
- 13 Aug 1947
- Application
- NDA006134-004