Details for New Drug Application (NDA): 210096
✉ Email this page to a colleague
NDA 210096 describes TRIENTINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Amneal, Chartwell Rx, Dr Reddys, Eci Pharms Llc, Endo Operations, Hetero Labs Ltd Iii, Lupin Ltd, MSN, Navinta Llc, Rising, Watson Labs Teva, and Zydus Pharms, and is included in thirteen NDAs. It is available from ten suppliers. Additional details are available on the TRIENTINE HYDROCHLORIDE profile page.
The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
The generic ingredient in TRIENTINE HYDROCHLORIDE is trientine hydrochloride. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the trientine hydrochloride profile page.
Summary for 210096
| Tradename: | TRIENTINE HYDROCHLORIDE |
| Applicant: | Endo Operations |
| Ingredient: | trientine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210096
| Mechanism of Action | Copper Chelating Activity Metal Chelating Activity |
Medical Subject Heading (MeSH) Categories for 210096
Suppliers and Packaging for NDA: 210096
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIENTINE HYDROCHLORIDE | trientine hydrochloride | CAPSULE;ORAL | 210096 | ANDA | Endo USA, Inc. | 49884-060 | 49884-060-01 | 100 CAPSULE in 1 BOTTLE (49884-060-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Sep 25, 2019 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
