Composition
- Active ingredients
- PROTRIPTYLINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.
- PROTRIPTYLINE HYDROCHLORIDE 5MG · TabletANDA073644-001 · Discontinued
- PROTRIPTYLINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA016012-002 · Discontinued
- PROTRIPTYLINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletThis page
- PROTRIPTYLINE HYDROCHLORIDE 10MG · TabletANDA073645-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA016012.
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
- Vivactil
- Active substance
- protriptyline hydrochloride
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Teva Womens
- Status
- Discontinued
- FDA approval
- 27 Sept 1967
- Application
- NDA016012-001