Details for New Drug Application (NDA): 085749
✉ Email this page to a colleague
NDA 085749 describes ENDEP, which is a drug marketed by Roche and is included in three NDAs. Additional details are available on the ENDEP profile page.
The generic ingredient in ENDEP is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
The generic ingredient in ENDEP is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 085749
| Tradename: | ENDEP |
| Applicant: | Roche |
| Ingredient: | amitriptyline hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085749
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CONCENTRATE;ORAL | Strength | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
